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

Coppertone waterBABIES Pure and Simple Free by

Drug Labeling and Warnings

Coppertone waterBABIES Pure and Simple Free by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Drug Facts

Active Ingredients

Active Ingredients Purpose

Avobenzone 3%, Homosalate 15%, Octisalate 5%,

Octocrylene 10%, Oxybenzone 6%.............................Sunscreen

Use

• helps prevent sunburn

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 and ask a doctor

Stop use and ask a doctor if a 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 Specturm SPF value of 15 or higher and other sun protection measures including: limit the 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

Water, Butylene Glycol, Microcrystalline Cellulose, Behenyl Alcohol, Glyceryl Stearate, Benzyl Alcohol, Palmitic Acid, Stearic Acid, Tocopherol (Vitamin E), Myristyl Alcohol, Cellulose Gum, Butylated PVP, Chlorphenesin, Lecithin, Cetyl Alcohol, Lauryl Alcohol, Disodium EDTA, Sodium Ascorbyl Phosphate

Questions?

Questions? 1-866-288-3330

Label 6 oz.

New Look

Coppertone®

SUNSCREEN LOTION

water

babies®

Pure & Simple

No Frangrance,

Parabens, PABA 50

Water Resistant

(80 Minutes)

Broad Spectrum

SPF 50

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

COPPERTONE WATERBABIES PURE AND SIMPLE FREE  SPF 50
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7409
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	153.15 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	102.1 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30.63 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	51.05 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	61.26 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CHLORPHENESIN (UNII: I670DAL4SZ)
CETYL ALCOHOL (UNII: 936JST6JCN)
DOCOSANOL (UNII: 9G1OE216XY)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PALMITIC ACID (UNII: 2V16EO95H1)
LAURYL ALCOHOL (UNII: 178A96NLP2)
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
.ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)

Product Characteristics
Color	white (WHITE TO OFF-WHITE)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-7409-1	177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/21/1999	09/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/21/1999	09/01/2021

Labeler - Bayer HealthCare LLC. (112117283)