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Neutrogena moistureshine lip soother with sunscreen spf 20, gleam 40 - Medication Information

Product NDC Code 69968-0850
Drug Name

Neutrogena moistureshine lip soother with sunscreen spf 20, gleam 40

Type Brand
Active Ingredients
Avobenzone 30 mg/g
Homosalate 100 mg/g
Octocrylene 100 mg/g
Route TOPICAL
Dosage Form GEL
Application Number M020
Labeler Name Johnson & Johnson Consumer Inc.
Packages
Package NDC Code Description
69968-0850-1 10 g in 1 tube (69968-0850-1)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Avobenzone (3%), Homosalate (10%), Octocrylene (10%) Active ingredients Avobenzone (3%), Homosalate (10%), Octocrylene (10%) Active ingredients Avobenzone (3%), Homosalate (10%), Octocrylene (10%) Active ingredients Avobenzone (3%), Homosalate (10%), 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 For Sunscreen Use • 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 For Sunscreen Use • 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 For Sunscreen Use • 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 For Sunscreen Use • 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 Polybutene, Bis-Diglyceryl Polyacyladipate-2, Glycerin, Octyldodecanol, Synthetic Beeswax, Diisocetyl Dodecanedioate, Ricinus Communis (Castor) Seed Oil, Behenyl Alcohol, Polyglyceryl-3 Stearate, Carthamus Tinctorius (Safflower) Seed Oil, Silica Silylate, Fragrance, Menthol, Spirulina Maxima Extract, Laminaria Saccharina, Extract, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Saccharin, Aloe Barbadensis Leaf Extract, chamomilla recutita (matricaria) flower extract, Cucumis Sativus (Cucumber) Fruit Extract, Ascorbyl Palmitate, Tocopherol, Glycine Soja (Soybean) Oil, Iron Oxides, Red 7 Lake, Blue 1 Lake Inactive ingredients Polybutene, Bis-Diglyceryl Polyacyladipate-2, Glycerin, Octyldodecanol, Synthetic Beeswax, Diisocetyl Dodecanedioate, Ricinus Communis (Castor) Seed Oil, Behenyl Alcohol, Polyglyceryl-3 Stearate, Carthamus Tinctorius (Safflower) Seed Oil, Silica Silylate, Fragrance, Menthol, Spirulina Maxima Extract, Laminaria Saccharina, Extract, Saccharin, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Aloe Barbadensis Leaf Extract, chamomilla recutita (matricaria) flower extract, Cucumis Sativus (Cucumber) Fruit Extract, Ascorbyl Palmitate, Tocopherol, Glycine Soja (Soybean) Oil, Red 7 Lake, Blue 1 Lake Inactive ingredients Polybutene, Bis-Diglyceryl Polyacyladipate-2, Glycerin, Octyldodecanol, Synthetic Beeswax, Ricinus Communis (Castor) Seed Oil, Diisocetyl Dodecanedioate, , Behenyl Alcohol, Polyglyceryl-3 Stearate, Carthamus Tinctorius (Safflower) Seed Oil, Silica Silylate, Fragrance, Menthol, Laminaria Saccharina Extract, Spirulina Maxima Extract, , Saccharin , Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, , Aloe Barbadensis Leaf Extract, chamomilla recutita (matricaria) flower extract, Cucumis Sativus (Cucumber) Fruit Extract, Ascorbyl Palmitate, Tocopherol, Glycine Soja (Soybean) Oil, Red 7 Lake, Blue 1 Lake Inactive ingredients Polybutene, Bis-Diglyceryl Polyacyladipate-2, Glycerin, Octyldodecanol, Synthetic Beeswax, Diisocetyl Dodecanedioate, Ricinus Communis (Castor) Seed Oil, Behenyl Alcohol, Polyglyceryl-3 Stearate, Carthamus Tinctorius (Safflower) Seed Oil, Silica Silylate, Fragrance, Menthol, Laminaria Saccharina Extract, Spirulina Maxima Extract, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Saccharin, Aloe Barbadensis Leaf Extract, chamomilla recutita (matricaria) flower extract, Cucumis Sativus (Cucumber) Fruit Extract, Tin Oxide, Ascorbyl Palmitate, Tocopherol, Glycine Soja (Soybean) Oil, Mica, Titanium Dioxide, Iron Oxides, Red 7 Lake, Blue 1 Lake

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.
Use • 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 Use • 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 Use • 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 Use • 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 MoistureShine Lip Soother with Sunscreen SPF 20, Shine 30 Avobenzone, Homosalate, Octocrylene GLYCERIN DIISOCETYL DODECANEDIOATE CASTOR OIL POLYGLYCERYL-3 STEARATE TOCOPHEROL HOMOSALATE HOMOSALATE OCTOCRYLENE OCTOCRYLENE D&C RED NO. 7 AVOBENZONE AVOBENZONE OCTYLDODECANOL POLYBUTENE (1400 MW) FERROUS OXIDE BIS-DIGLYCERYL POLYACYLADIPATE-2 DOCOSANOL SAFFLOWER OIL MENTHOL ALOE VERA LEAF CHAMOMILE SYNTHETIC BEESWAX CUCUMBER SACCHARINA LATISSIMA SPIRULINA MAXIMA SACCHARIN ASCORBYL PALMITATE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) SOYBEAN OIL FD&C BLUE NO. 1 ALUMINUM LAKE Neutrogena MoistureShine Lip Soother with Sunscreen SPF 20, Glow 70 Avobenzone, Homosalate, Octocrylene STANNIC OXIDE GLYCERIN DIISOCETYL DODECANEDIOATE CASTOR OIL POLYGLYCERYL-3 STEARATE TOCOPHEROL HOMOSALATE HOMOSALATE OCTOCRYLENE OCTOCRYLENE D&C RED NO. 7 AVOBENZONE AVOBENZONE OCTYLDODECANOL POLYBUTENE (1400 MW) FERROUS OXIDE BIS-DIGLYCERYL POLYACYLADIPATE-2 DOCOSANOL SAFFLOWER OIL MENTHOL ALOE VERA LEAF CHAMOMILE SYNTHETIC BEESWAX CUCUMBER ASCORBYL PALMITATE SACCHARINA LATISSIMA SPIRULINA MAXIMA SACCHARIN FD&C BLUE NO. 1 ALUMINUM LAKE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) SOYBEAN OIL TITANIUM DIOXIDE Neutrogena MoistureShine Lip Soother with Sunscreen SPF 20, Gleam 40 Avobenzone, Homosalate, Octocrylene GLYCERIN DIISOCETYL DODECANEDIOATE CASTOR OIL POLYGLYCERYL-3 STEARATE TOCOPHEROL HOMOSALATE HOMOSALATE OCTOCRYLENE OCTOCRYLENE D&C RED NO. 7 AVOBENZONE AVOBENZONE OCTYLDODECANOL POLYBUTENE (1400 MW) BIS-DIGLYCERYL POLYACYLADIPATE-2 DOCOSANOL SAFFLOWER OIL MENTHOL ALOE VERA LEAF CHAMOMILE SYNTHETIC BEESWAX CUCUMBER SACCHARINA LATISSIMA SPIRULINA MAXIMA SACCHARIN ASCORBYL PALMITATE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) SOYBEAN OIL FD&C BLUE NO. 1 ALUMINUM LAKE Neutrogena MoistureShine Lip Soother with Sunscreen SPF 20, Glaze 60 Avobenzone, Homosalate, Octocrylene GLYCERIN DIISOCETYL DODECANEDIOATE CASTOR OIL POLYGLYCERYL-3 STEARATE TOCOPHEROL HOMOSALATE HOMOSALATE OCTOCRYLENE OCTOCRYLENE D&C RED NO. 7 AVOBENZONE AVOBENZONE OCTYLDODECANOL POLYBUTENE (1400 MW) BIS-DIGLYCERYL POLYACYLADIPATE-2 DOCOSANOL SAFFLOWER OIL MENTHOL ALOE VERA LEAF CHAMOMILE SYNTHETIC BEESWAX CUCUMBER SACCHARINA LATISSIMA SPIRULINA MAXIMA SACCHARIN ASCORBYL PALMITATE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) SOYBEAN OIL FD&C BLUE NO. 1 ALUMINUM LAKE

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.
PRINCIPAL DISPLAY PANEL - 10 g Tube Label, Shine 30 LIP SOOTHER MOISTURE SHINE cooling hydragel promotes hydration for smooth lips sunscreen SPF 20 SHINE 30 Neutrogena ® NET WT. 0.35 OZ. (10G) Shine-30 PRINCIPAL DISPLAY PANEL - 10 g Tube Label, Gleam 40 LIP SOOTHER MOISTURE SHINE cooling hydragel promotes hydration for smooth lips sunscreen SPF 20 GLEAM 40 Neutrogena ® NET WT. 0.35 OZ. (10G) Gleam-40 PRINCIPAL DISPLAY PANEL - 10 g Tube Label, Glaze 60 LIP SOOTHER MOISTURE SHINE cooling hydragel promotes hydration for smooth lips sunscreen SPF 20 GLAZE 60 Neutrogena ® NET WT. 0.35 OZ. (10G) Glaze 60 PRINCIPAL DISPLAY PANEL - 10 g Tube Label, Glow 70 LIP SOOTHER MOISTURE SHINE cooling hydragel promotes hydration for smooth lips sunscreen SPF 20 GLOW 70 Neutrogena ® NET WT. 0.35 OZ. (10G) Glow-70

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? Call toll free 800-480-4812 or 215-273-8755 (collect) or visit www.neutrogena.com Questions? Call toll free 800-480-4812 or 215-273-8755 (collect) or visit www.neutrogena.com Questions? Call toll free 800-480-4812 or 215-273-8755 (collect) or visit www.neutrogena.com Questions? 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