COPPERTONE WATERBABIES SUNSCREEN SPF 50- avobenzone 3%, homosalate 9%, octisalate 4.5%, octocrylene 9% aerosol, spray

Coppertone Waterbabies Sunscreen SPF 50 by

Drug Labeling and Warnings

Coppertone Waterbabies Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Beiersdorf Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

(To Deliver) Avobenzone 3%, Homosalate 9%, Octisalate 4.5%, Octocrylene 9%

Purpose

Sunscreen

Use

■ helps prevent sunburn

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.

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

■ protect this product from excessive heat and direct sun

■ store between 20˚ to 25˚C (68˚ to 77˚F)

■ may stain or damage some fabrics or surfaces

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

Questions?

1-866-288-3330

PRINCIPAL DISPLAY PANEL

Coppertone ® Sunscreen Lotion Spray

#1 Pediatrician Recommended Sunscreen Brand

water babies

50

Hypoallergenic

With Aloe and Nourishing Vitamin E

Free of Oxybenzone, Octinoxate, Dyes & PABA

Water Resistant (80 Minutes)

Broad Specturm SPF 50

INGREDIENTS AND APPEARANCE

COPPERTONE WATERBABIES SUNSCREEN SPF 50 
avobenzone 3%, homosalate 9%, octisalate 4.5%, octocrylene 9% aerosol, spray

Product 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)