COPPERTONE WATERBABIES PURE AND SIMPLE LIGHT SPF 50- avobenzone, homosalate, octisalate, and octocrylene lotion
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 Light Lotion SPF 50

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 9%,

Octisalate 4.5%, Octocrylene 9%

Purpose

Sunscreen

Uses

■ helps prevent sunburn

Warnings

Warnings
For external use only

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.

Stop use

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

■ apply liberally 15 minutes before sun exposure

■ 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

■ may stain or damage some fabrics or surfaces

Inactive ingredients

Inactive ingredients water, aloe barbadensis leaf juice, C12-15 alkyl benzoate, neopentyl glycol diheptanoate, butylene glycol, stryrene/acrylates copolymer, VP/eicosene copolymer, 1,2-hexanediol, hydroxyacetophenone, tocopherol, acrylates/C10-13 alkyl acrylate crosspolymer, potassium hydroxide, disodium EDTA

Questions

Questions? 1-866-288-3330

Product label 6 oz.

New

Coppertone®

SUNSCREEN LOTION

water

babies®

Pure & Simple

Light Lotion

No fragrance,

Parabens, PABA

Water Resistant

(80 Minutes)

Broad Spectrum

SPF 50

Pediatrician

Recommended

Brand

Product label

COPPERTONE WATERBABIES PURE AND SIMPLE LIGHT SPF 50
avobenzone, homosalate, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11523-7433
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30.1 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45.1 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	90.3 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	90.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
TOCOPHEROL (UNII: R0ZB2556P8)

Product Characteristics
Color	white (Off white to light yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11523-7433-1	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2017	09/01/2021
2	NDC:11523-7433-2	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2017	09/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/01/2017	09/01/2021

Labeler - Bayer HealthCare LLC. (112117283)

Revised: 11/2019

Document Id: 9831e5b1-b7b1-6d26-e053-2a95a90a176a

Set id: 5fd3abfe-4169-262a-e053-2991aa0a2655

Version: 2

Effective Time: 20191125

Bayer HealthCare LLC.