Waterbabies Lotion Spray SPF 50 UI 1614232

Waterbabies Lotion Spray SPF 50 UI 1614232

Drug Labeling and Warnings

Drug Details

k">

COPPERTONE WATER BABIES- avobenzone, homosalate, octisalate, octocrylene aerosol, spray 
Bayer HealthCare LLC.

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.

----------

Waterbabies Lotion Spray SPF 50 UI 1614232

Drug Facts

Active ingredients

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

Purpose

Sunscreen

Uses

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

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 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.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if rash occurs

Directions

Directions

■ shake well before each use

■ apply liberally 15 minutes before sun exposure and rub into skin

■ do not spray directly on face. Spray into hands and apply to face.

■ use in well-ventilated areas

■ 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

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

Improved Formula

Coppertone®

SUNSCREEN SPRAY

water

babies

LOTION SPRAY

Hypoallergenic & Gentle 50

#1 Pediatrician

Recommended brand

No Dyes, PABA, Oxybenzone

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

NET WT 6 OZ (170 g)

Bottle 6 oz.

COPPERTONE WATER BABIES 
avobenzone, homosalate, octisalate, octocrylene aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11523-7437
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE90 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE90 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
TOCOPHEROL (UNII: R0ZB2556P8)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
2'-HYDROXYACETOPHENONE (UNII: 3E533Z76W0)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
DIMETHYL ETHER (UNII: AM13FS69BX)  
Product Characteristics
Colorwhite (Off-white to light yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11523-7437-1170 g in 1 CAN; Type 0: Not a Combination Product11/01/2018
2NDC: 11523-7437-2269 g in 1 CAN; Type 0: Not a Combination Product11/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/01/2018
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 9/2018
 
Bayer HealthCare LLC.


© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.