Label: COPPERTONE WATERBABIES SUNSCREEN SPF 50- avobenzone 3%, homosalate 9%, octisalate 4.5%, octocrylene 9% aerosol, spray
- NDC Code(s): 66800-4232-6, 66800-4232-9
- Packager: Beiersdorf Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated March 5, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
- Use
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Warnings
For external use only
Flammable: Do not use near heat, flame, or while smoking
Do not use on damaged or broken skin
When using this product
■ keep away from face to avoid breathing it■ keep out of eyes. Rinse with water to remove.
■ use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
■ do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120˚F.
Stop use and ask a doctor if rash occurs
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
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Directions
■ shake well before each use
■ spray liberally and spread evenly by hand 15 minutes before sun exposure
■ hold container 4 to 6 inches from the skin to apply
■ do not spray directly into face. Spray on hands then apply to face.
■ do not apply in windy conditions
■ use in a well-ventilated area
■ reapply:
■ after 80 minutes of swimming or sweating
■ immediately after towel drying
■ at least every 2 hours
■ 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-sleeve shirts, pants, hats, and sunglasses
■ children under 6 months: Ask a doctor
- Other information
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Inactive ingredients
water, dimethyl ether, aloe barbadensis leaf juice, C12-15 alkyl benzoate, neopentyl glycol diheptanoate, butylene glycol, styrene/acrylates copolymer, VP/eicosene copolymer, 1,2-hexanediol, hydroxyacetophenone, fragrance, tocopherol, acrylates/C10-30 alkyl acrylate crosspolymer, potassium hydroxide, disodium EDTA
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INGREDIENTS AND APPEARANCE
COPPERTONE WATERBABIES SUNSCREEN SPF 50
avobenzone 3%, homosalate 9%, octisalate 4.5%, octocrylene 9% aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66800-4232 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 9 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 9 g in 100 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g in 100 g Inactive Ingredients Ingredient Name Strength STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) WATER (UNII: 059QF0KO0R) DIMETHYL ETHER (UNII: AM13FS69BX) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) CARBOMER INTERPOLYMER TYPE C (ALLYL SUCROSE CROSSLINKED) (UNII: U990QE4LKP) TOCOPHEROL (UNII: R0ZB2556P8) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66800-4232-6 170 g in 1 CAN; Type 0: Not a Combination Product 11/01/2021 2 NDC:66800-4232-9 269 g in 1 CAN; Type 0: Not a Combination Product 11/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/01/2021 Labeler - Beiersdorf Inc (001177906)
