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Chapstick active 2in1 variety pack - Medication Information

Product NDC Code 0573-0803
Drug Name

Chapstick active 2in1 variety pack

Type Brand
Dosage Form KIT
Application Number M016
Labeler Name Haleon US Holdings LLC
Packages
Package NDC Code Description
0573-0803-01 1 kit in 1 package (0573-0803-01) * 5 g in 1 tube (0573-0801-01) * 5 g in 1 tube (0573-0802-01) * 5 g in 1 tube (0573-0800-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Zinc Oxide 20.5%

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 liberally 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating children under 6 months of age: Ask a doctor 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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients (Unscented) aloe barbadensis leaf extract, argania spinosa kernel oil, astrocaryum murumuru seed butter, beeswax, bisabolol, butyrospermum parkii (shea) butter, caprylic/capric triglyceride, carthamus tinctorius (safflower) seed oil, cocos nucifera (coconut) oil, copernicia cerifera (carnauba) wax, euphorbia cerifera (candelilla) wax, helianthus annuus (sunflower) seed oil, jojoba esters, mangifera indica (mango) seed butter, polyhydroxystearic acid, tocopherol, tocopheryl acetate Inactive ingredients (Fresh Mint) aloe barbadensis leaf extract, argania spinosa kernel oil, astrocaryum murumuru seed butter, beeswax, bisabolol, butyrospermum parkii (shea) butter, caprylic/capric triglyceride, carthamus tinctorius (safflower) seed oil, cocos nucifera (coconut) oil, copernicia cerifera (carnauba) wax, euphorbia cerifera (candelilla) wax, helianthus annuus (sunflower) seed oil, jojoba esters, mangifera indica (mango) seed butter, natural flavors, polyhydroxystearic acid, tocopherol, tocopheryl acetate, yellow 6 lake Inactive ingredients (Wild Berry) aloe barbadensis leaf extract, argania spinosa kernel oil, astrocaryum murumuru seed butter, beeswax, bisabolol, butyrospermum parkii (shea) butter, caprylic/capric triglyceride, carthamus tinctorius (safflower) seed oil, cocos nucifera (coconut) oil, copernicia cerifera (carnauba) wax, euphorbia cerifera (candelilla) wax, helianthus annuus (sunflower) seed oil, jojoba esters, mangifera indica (mango) seed butter, natural flavors, polyhydroxystearic acid, ricinus communis (castor) seed oil, tocopherol, tocopheryl acetate

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

Purpose

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

Spl product data elements

Usually a list of ingredients in a drug product.
Chapstick Active 2in1 Variety Pack zinc oxide Chapstick Active 2in1 Unscented zinc oxide ALOE VERA LEAF ARGAN OIL ASTROCARYUM MURUMURU SEED BUTTER YELLOW WAX SHEA BUTTER MEDIUM-CHAIN TRIGLYCERIDES SAFFLOWER OIL COCONUT OIL CARNAUBA WAX CANDELILLA WAX SUNFLOWER OIL HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 57-61) HYDROGENATED JOJOBA OIL, RANDOMIZED MANGIFERA INDICA SEED BUTTER POLYHYDROXYSTEARIC ACID (2300 MW) TOCOPHEROL .ALPHA.-TOCOPHEROL ACETATE ZINC OXIDE ZINC OXIDE Chapstick Active 2in1 Fresh Mint zinc oxide ALOE VERA LEAF ARGAN OIL ASTROCARYUM MURUMURU SEED BUTTER YELLOW WAX .ALPHA.-BISABOLOL, (+/-)- SHEA BUTTER MEDIUM-CHAIN TRIGLYCERIDES SAFFLOWER OIL COCONUT OIL CARNAUBA WAX CANDELILLA WAX SUNFLOWER OIL HYDROGENATED JOJOBA OIL, RANDOMIZED MANGIFERA INDICA SEED POLYHYDROXYSTEARIC ACID (2300 MW) TOCOPHEROL .ALPHA.-TOCOPHEROL ACETATE ZINC OXIDE ZINC OXIDE Chapstick Active 2in1 Wild Berry zinc oxide ALOE VERA LEAF ARGAN OIL ASTROCARYUM MURUMURU SEED BUTTER YELLOW WAX .ALPHA.-BISABOLOL, (+/-)- SHEA BUTTER MEDIUM-CHAIN TRIGLYCERIDES SAFFLOWER COCONUT OIL CARNAUBA WAX CANDELILLA WAX SUNFLOWER OIL HYDROGENATED JOJOBA OIL, RANDOMIZED MANGIFERA INDICA SEED BUTTER POLYHYDROXYSTEARIC ACID (2300 MW) CASTOR OIL TOCOPHEROL .ALPHA.-TOCOPHEROL ACETATE ZINC OXIDE ZINC OXIDE

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 ChapStick ® NEW BRAND LIP CARE SUNSCREEN BROAD SPECTRUM SPF 25 ACTIVE 2in1 mineral based SPF 25 lock in moisture VARIETY PACK REEF FRIENDLY FREE FROM parabens phthalates preservatives ALL WEATHER 3 STICKS NET WT 0.18 OZ (5 g) EACH 200219 Chapstick Active 2 in 1 Variety Pack 3 sticks 0.18 oz (5 g) each

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.
ChapStick® ACTIVE 2in1 | Unscented | Fresh Mint | Wild Berry Additional information Paraben Free Dist. by: GSK CH, Warren, NJ 07059 For most recent product information, visit www.chapstick.com Trademarks owned or licensed by GSK ©2022 GSK or licensor For US Patent or Application status see www.productpats.com 200219

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

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.

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 weekdays from 8 AM to 6 PM at 1-800-245-1040

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.

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at 20-25°C (68-77°F) protect the product from excessive heat and direct sun

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. 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