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

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.

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Coppertone Waterbabies Lotion Spray SPF 50

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

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

WB Lotion Spray

COPPERTONE WATERBABIES SUNSCREEN SPF 50 
avobenzone 3%, homosalate 9%, octisalate 4.5%, octocrylene 9% aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66800-4232
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66800-4232-6170 g in 1 CAN; Type 0: Not a Combination Product11/01/2021
2NDC:66800-4232-9269 g in 1 CAN; Type 0: Not a Combination Product11/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/01/2021
Labeler - Beiersdorf Inc (001177906)

Revised: 3/2023
Document Id: f6295926-40bc-3309-e053-2a95a90a0d6f
Set id: d53e1253-f6a4-4f3d-e053-2a95a90a79ed
Version: 2
Effective Time: 20230305
 
Beiersdorf Inc