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Neutrogena revitalizing lip balm broad spectrum spf 20 - soft caramel 50 - Medication Information

Product NDC Code 69968-0883
Drug Name

Neutrogena revitalizing lip balm broad spectrum spf 20 - soft caramel 50

Type Brand
Active Ingredients
Avobenzone 30 mg/g
Homosalate 60 mg/g
Octocrylene 100 mg/g
Route TOPICAL
Dosage Form STICK
Application Number M020
Labeler Name Kenvue Brands LLC
Packages
Package NDC Code Description
69968-0883-1 1 canister in 1 blister pack (69968-0883-1) / 4.2 g in 1 canister
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Avobenzone (3%), Homosalate (6%), Octocrylene (10%) Active ingredients Avobenzone (3%), Homosalate (6%), Octocrylene (10%) Active ingredients Avobenzone (3%), Homosalate (6%), Octocrylene (10%) Active ingredients Avobenzone (3%), Homosalate (6%), Octocrylene (10%)

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions ■ apply generously and evenly 15 minutes before sun exposure ■ reapply at least every 2 hours ■ use a water resistant sunscreen if swimming or sweating ■ Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: ■ limit time in the sun, especially from 10 a.m. – 2 p.m. ■ wear long-sleeved shirts, pants, hats, and sunglasses ■ children under 6 months of age: Ask a doctor Directions ■ apply generously and evenly 15 minutes before sun exposure ■ reapply at least every 2 hours ■ use a water resistant sunscreen if swimming or sweating ■ Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: ■ limit time in the sun, especially from 10 a.m. – 2 p.m. ■ wear long-sleeved shirts, pants, hats, and sunglasses ■ children under 6 months of age: Ask a doctor Directions ■ apply generously and evenly 15 minutes before sun exposure ■ reapply at least every 2 hours ■ use a water resistant sunscreen if swimming or sweating ■ Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:■ limit time in the sun, especially from 10 a.m. – 2 p.m.■ wear long-sleeved shirts, pants, hats, and sunglasses■ children under 6 months of age: Ask a doctor Directions ■ apply generously and evenly 15 minutes before sun exposure ■ reapply at least every 2 hours ■ use a water resistant sunscreen if swimming or sweating ■ Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:■ limit time in the sun, especially from 10 a.m. – 2 p.m. ■ wear long-sleeved shirts, pants, hats, and sunglasses ■ children under 6 months of age: Ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Hydrogenated Polyisobutene, Polybutene, Petrolatum, Phenyl Trimethicone, Ozokerite, Diethylhexyl 2,6-Naphthalate, Hydrogenated Lanolin, Synthetic Wax, Bis-Behenyl/Isostearyl/Phytosteryl Dimer Dilinoleyl Dimer Dilinoleate, Butyrospermum Parkii (Shea) Butter, Euphorbia Cerifera (Candelilla) Wax, Cetyl Lactate, Myristyl Myristate, Mica, Silica, Copernicia Cerifera (Carnauba) Wax, Stearoxymethicone/Dimethicone Copolymer, Ethylhexyl Palmitate, Tribehenin, Flavor, Fragrance, Silica Silylate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Sorbitan Isostearate, Isopropyl Titanium Triisostearate, Palmitoyl Tripeptide-1, Iron Oxides,Titanium Dioxide, Red 7 Lake Inactive ingredients Hydrogenated Polyisobutene, Polybutene, Petrolatum, Phenyl Trimethicone, Ozokerite, Diethylhexyl 2,6-Naphthalate, Hydrogenated Lanolin, Synthetic Wax, Bis-Behenyl/Isostearyl/Phytosteryl Dimer Dilinoleyl Dimer Dilinoleate, Butyrospermum Parkii (Shea) Butter, Euphorbia Cerifera (Candelilla) Wax, Cetyl Lactate, Myristyl Myristate, Silica, Copernicia Cerifera (Carnauba) Wax, Stearoxymethicone/Dimethicone Copolymer, Ethylhexyl Palmitate, Tribehenin, Flavor, Fragrance, Silica Silylate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Sorbitan Isostearate, Isopropyl Titanium Triisostearate, Palmitoyl Tripeptide-1, Iron Oxides,Titanium Dioxide, Red 7 Lake Inactive ingredients Hydrogenated Polyisobutene, Petrolatum, Polybutene, Phenyl Trimethicone, Ozokerite, Diethylhexyl 2,6-Naphthalate, Hydrogenated Lanolin, Synthetic Wax, Bis-Behenyl/Isostearyl/Phytosteryl Dimer Dilinoleyl Dimer Dilinoleate, Butyrospermum Parkii (Shea) Butter, Euphorbia Cerifera (Candelilla) Wax, Cetyl Lactate, Myristyl Myristate, Silica, Copernicia Cerifera (Carnauba) Wax, Stearoxymethicone/Dimethicone Copolymer, Ethylhexyl Palmitate, Tribehenin, Flavor, Fragrance, Silica Silylate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Sorbitan Isostearate, Isopropyl Titanium Triisostearate, Palmitoyl Tripeptide-1, Mica, Titanium Dioxide, Iron Oxides Inactive ingredients Hydrogenated Polyisobutene, Petrolatum, Polybutene, Phenyl Trimethicone, Ozokerite, Diethylhexyl 2,6-Naphthalate, Hydrogenated Lanolin, Synthetic Wax, Bis-Behenyl/Isostearyl/Phytosteryl Dimer Dilinoleyl Dimer Dilinoleate, Butyrospermum Parkii (Shea) Butter, Euphorbia Cerifera (Candelilla) Wax, Cetyl Lactate, Myristyl Myristate, Silica, Copernicia Cerifera (Carnauba) Wax, Stearoxymethicone/Dimethicone Copolymer, Ethylhexyl Palmitate, Tribehenin, Flavor, Fragrance, Silica Silylate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Sorbitan Isostearate, Isopropyl Titanium Triisostearate, Palmitoyl Tripeptide-1,Titanium Dioxide, Red 6 Lake, Red 7 Lake, Iron Oxides

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Uses helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun Uses ■ helps prevent sunburn ■ if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun Uses ■ helps prevent sunburn ■ if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun Uses ■ helps prevent sunburn ■ if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Purpose

Information about the drug product’s indications for use.
Purpose Sunscreen Purpose Sunscreen Purpose Sunscreen Purpose Sunscreen

Spl product data elements

Usually a list of ingredients in a drug product.
Neutrogena Revitalizing Lip Balm Broad Spectrum SPF 20 - Healthy Blush 20 Avobenzone, Homosalate, Octocrylene POLYBUTENE (1400 MW) PHENYL TRIMETHICONE LANOLIN ALCOHOLS CANDELILLA WAX SORBITAN ISOSTEARATE TITANIUM DIOXIDE PETROLATUM SHEA BUTTER OCTOCRYLENE OCTOCRYLENE CERESIN DIETHYLHEXYL 2,6-NAPHTHALATE SILICON DIOXIDE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) FERRIC OXIDE RED AVOBENZONE AVOBENZONE CETYL LACTATE MYRISTYL MYRISTATE ETHYLHEXYL PALMITATE D&C RED NO. 7 HOMOSALATE HOMOSALATE CARNAUBA WAX ISOPROPYL TITANIUM TRIISOSTEARATE PALMITOYL TRIPEPTIDE-1 HYDROGENATED POLYISOBUTENE (1300 MW) TRIBEHENIN Neutrogena Revitalizing Lip Balm Broad Spectrum SPF 20 - Sheer Shimmer 10 Avobenzone, Homosalate, Octocrylene POLYBUTENE (1400 MW) PHENYL TRIMETHICONE LANOLIN ALCOHOLS CANDELILLA WAX SORBITAN ISOSTEARATE TITANIUM DIOXIDE PETROLATUM SHEA BUTTER OCTOCRYLENE OCTOCRYLENE CERESIN DIETHYLHEXYL 2,6-NAPHTHALATE SILICON DIOXIDE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) FERRIC OXIDE RED AVOBENZONE AVOBENZONE CETYL LACTATE MYRISTYL MYRISTATE ETHYLHEXYL PALMITATE D&C RED NO. 7 HOMOSALATE HOMOSALATE MICA CARNAUBA WAX ISOPROPYL TITANIUM TRIISOSTEARATE PALMITOYL TRIPEPTIDE-1 HYDROGENATED POLYISOBUTENE (1300 MW) TRIBEHENIN Neutrogena Revitalizing Lip Balm Broad Spectrum SPF 20 - Sunny Berry 30 Avobenzone, Homosalate, Octocrylene POLYBUTENE (1400 MW) PHENYL TRIMETHICONE LANOLIN ALCOHOLS CANDELILLA WAX SORBITAN ISOSTEARATE TITANIUM DIOXIDE PETROLATUM AVOBENZONE AVOBENZONE CETYL LACTATE MYRISTYL MYRISTATE ETHYLHEXYL PALMITATE D&C RED NO. 7 CERESIN SHEA BUTTER DIETHYLHEXYL 2,6-NAPHTHALATE SILICON DIOXIDE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) FERRIC OXIDE RED HOMOSALATE HOMOSALATE MICA CARNAUBA WAX ISOPROPYL TITANIUM TRIISOSTEARATE PALMITOYL TRIPEPTIDE-1 HYDROGENATED POLYISOBUTENE (1300 MW) TRIBEHENIN OCTOCRYLENE OCTOCRYLENE Neutrogena Revitalizing Lip Balm Broad Spectrum SPF 20 - Fresh Plum 60 Avobenzone, Homosalate, Octocrylene POLYBUTENE (1400 MW) PHENYL TRIMETHICONE LANOLIN ALCOHOLS CANDELILLA WAX SORBITAN ISOSTEARATE TITANIUM DIOXIDE PETROLATUM SHEA BUTTER DIETHYLHEXYL 2,6-NAPHTHALATE SILICON DIOXIDE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) FERRIC OXIDE RED AVOBENZONE AVOBENZONE CETYL LACTATE MYRISTYL MYRISTATE ETHYLHEXYL PALMITATE D&C RED NO. 7 HOMOSALATE HOMOSALATE MICA CARNAUBA WAX ISOPROPYL TITANIUM TRIISOSTEARATE PALMITOYL TRIPEPTIDE-1 HYDROGENATED POLYISOBUTENE (1300 MW) TRIBEHENIN OCTOCRYLENE OCTOCRYLENE CERESIN Neutrogena Revitalizing Lip Balm Broad Spectrum SPF 20 - Petal Glow 40 Avobenzone, Homosalate, Octocrylene POLYBUTENE (1400 MW) PHENYL TRIMETHICONE LANOLIN ALCOHOLS CANDELILLA WAX SORBITAN ISOSTEARATE TITANIUM DIOXIDE PETROLATUM SHEA BUTTER OCTOCRYLENE OCTOCRYLENE CERESIN DIETHYLHEXYL 2,6-NAPHTHALATE SILICON DIOXIDE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) FERRIC OXIDE RED AVOBENZONE AVOBENZONE CETYL LACTATE MYRISTYL MYRISTATE ETHYLHEXYL PALMITATE D&C RED NO. 7 HOMOSALATE HOMOSALATE CARNAUBA WAX ISOPROPYL TITANIUM TRIISOSTEARATE PALMITOYL TRIPEPTIDE-1 HYDROGENATED POLYISOBUTENE (1300 MW) TRIBEHENIN Neutrogena Revitalizing Lip Balm Broad Spectrum SPF 20 - Soft Caramel 50 Avobenzone, Homosalate, Octocrylene POLYBUTENE (1400 MW) PHENYL TRIMETHICONE LANOLIN ALCOHOLS CANDELILLA WAX SORBITAN ISOSTEARATE TITANIUM DIOXIDE PETROLATUM SHEA BUTTER OCTOCRYLENE OCTOCRYLENE CERESIN DIETHYLHEXYL 2,6-NAPHTHALATE SILICON DIOXIDE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) FERRIC OXIDE RED AVOBENZONE AVOBENZONE CETYL LACTATE MYRISTYL MYRISTATE ETHYLHEXYL PALMITATE HOMOSALATE HOMOSALATE MICA CARNAUBA WAX ISOPROPYL TITANIUM TRIISOSTEARATE PALMITOYL TRIPEPTIDE-1 HYDROGENATED POLYISOBUTENE (1300 MW) TRIBEHENIN

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Neutrogena Revitalizing Lip Balm Broad Spectrum SPF 20 - 4.2g Canister in Blister Pack Label - Sunny Berry 30 SUNNY BERRY 30 REVITALIZING LIP BALM In one week, improve texture of lips for softer, healthier-looking lips. Broad Spectrum SPF 20 Neutrogena ® NET WT. 0.15 OZ. (4.2G) 69968-0886 Neutrogena Revitalizing Lip Balm Broad Spectrum SPF 20 - 4.2g Canister in Blister Pack Label - Sheer Shimmer 10 SHEER SHIMMER 10 REVITALIZING LIP BALM In one week, improve texture of lips for softer, healthier-looking lips. sunscreen Broad Spectrum SPF 20 Neutrogena ® NET WT. 0.15 OZ. (4.2G) 69968-0882 Neutrogena Revitalizing Lip Balm Broad Spectrum SPF 20 - 4.2g Canister in Blister Pack Label - Fresh Plum 60 FRESH PLUM 60 REVITALIZING LIP BALM In one week, improve texture of lips for softer, healthier-looking lips. Broad Spectrum SPF 20 Neutrogena ® NET WT. 0.15 OZ. (4.2G) 69968-0887_Fresh Plum_1 Neutrogena Revitalizing Lip Balm Broad Spectrum SPF 20 - 4.2g Canister in Blister Pack Label - Petal Glow 40 PETAL GLOW 40 REVITALIZING LIP BALM in one week, improve texture of lips for softer, healthier-looking lips. sunscreen broad spectrum SPF 20 Neutrogena ® NET WT. 0.15 OZ. (4.2G) 69968-0885_Petal Glow Neutrogena Revitalizing Lip Balm Broad Spectrum SPF 20 - 4.2g Canister in Blister pack Label - Soft Caramel 50 SOFT CARAMEL 50 REVITALIZING LIP BALM In one week, improve texture of lips for softer, healthier-looking lips. sunscreen Broad Spectrum SPF 20 Neutrogena ® NET WT. 0.15 OZ. (4.2G) 69968-0883_Soft Caramel Neutrogena Revitalizing Lip Balm Broad Spectrum SPF 20 - 4.2g Canister in Blister pack Label - Healthy Blush 20 HEALTHY BLUSH 20 REVITALIZING LIP BALM in one week, improve texture of lips for softer, healthier-looking lips. sunscreen broad spectrum SPF 20 Neutrogena ® NET WT. 0.15 OZ. (4.2G) 69968-0884_Healthy Blush 20

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558 Drug Facts Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558 Drug Facts Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558 Drug Facts Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
■ Do not use ■ on damaged or broken skin ■ Do not use ■ on damaged or broken skin ■ Do not use ■ on damaged or broken skin ■ Do not use ■ on damaged or broken skin

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? Call toll-free 800-480-4812 or 215-273-8755 (collect) or visit www.neutrogena.com Questions or comments? Questions Or Comments? Call toll-free 800-480-4812 or 215-273-8755 (collect) or visit www.neutrogena.com Questions or comments? Questions Or Comments? Call toll-free 800-480-4812 or 215-273-8755 (collect) or visit www.neutrogena.com Questions or comments? Questions Or Comments? Call toll-free 800-480-4812 or 215-273-8755 (collect) or visit www.neutrogena.com

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if ■ rash occurs. Stop use and ask a doctor if .rash occurs. Stop use and ask a doctor if. rash occurs. Stop use and ask a doctor if. rash occurs.

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
■ When using this product ■ keep out of eyes. Rinse with water to remove. When using this product keep out of eyes. Rinse with water to remove. ■ When using this product ■ keep out of eyes. Rinse with water to remove When using this product keep out of eyes. Rinse with water to remove.

Storage and handling

Information about safe storage and handling of the drug product.
Other information protect this product from excessive heat and direct sun may stain some fabrics Other information ■ protect this product from excessive heat and direct sun ■ may stain some fabrics Other information ■ protect this product from excessive heat and direct sun ■ may stain some fabrics Other information ■ protect this product from excessive heat and direct sun ■ may stain some fabrics

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only ■ Do not use ■ on damaged or broken skin ■ When using this product ■ keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if ■ rash occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Warnings For external use only ■ Do not use ■ on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if .rash occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away Warnings For external use only ■ Do not use ■ on damaged or broken skin ■ When using this product ■ keep out of eyes. Rinse with water to remove Stop use and ask a doctor if. rash occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away Warnings For external use only ■ Do not use ■ on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if. rash occurs. Keep out of reach of children . If swallowed, get medical help or contact a Poison Control Center right away

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API