Coppertone Waterbabies Pure & Simple Lotion Spray SPF 50 (Colombia)

Coppertone Waterbabies Pure & Simple Lotion Spray SPF 50 (Colombia)

Drug Labeling and Warnings

Drug Details

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COPPERTONE WATERBABIES PURE AND SIMPLE SPF 50- avobenzone, homosalate, octisalate, octocrylene, oxybenzone 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.

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Coppertone Waterbabies Pure & Simple Lotion Spray SPF 50 (Colombia)

Drug Facts

Active ingredients

Active ingredients

(To Deliver) Avobenzone 3%, Homosalate 13%, Octisalate 5%,

Octocrylene 2%, Oxybenzone 4%

Purpose

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

Warnings
For external use only

Flammable: Do not use near heat, flame, or while smoking.

Do not use

Do not use on damaged or broken skin

When using this product

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.

Stop use and ask a doctor if

Stop use and ask a doctor if rash occurs

Keep out of reach of children

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

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

■may stain or damage some fabrics or surfaces

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

■protect this product from excessive heat and direct sun

Inactive ingredients

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, tocopherol, acrylates/C10-30 alkyl acrylate crosspolymer, potassium hydroxide, disodium EDTA

Questions

Questions? 1-866-288-3330

Label 6 oz.

Improved Formula

Coppertone®

SUNSCREEN SPRAY

water

babies®

Pure & Simple

Lotion Spray

No Fragrance,

Parabens, PABA 50

Water Resistant

(80 Minutes)

Broad Spectrum

SPF 50

#1

Pediatrician

Recommended

Brand

Bottle label 6 oz.

COPPERTONE WATERBABIES PURE AND SIMPLE SPF 50 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11523-7435
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45.1 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30.1 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE90.3 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE90.3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
WATER (UNII: 059QF0KO0R)  
TOCOPHEROL (UNII: R0ZB2556P8)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Product Characteristics
Colorwhite (Off white to light yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11523-7435-1170 g in 1 CAN; Type 0: Not a Combination Product02/05/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/05/2018
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 2/2018
 
Bayer HealthCare LLC.


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