COPPERTONE WATER BABIES SPF 50- avobenzone, homosalate, octisalate, and octocrylene lotion

Coppertone Water Babies SPF 50 by

Drug Labeling and Warnings

Coppertone Water Babies SPF 50 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

Avobenzone 3%, Homosalate 10%,

Octisalate 4.5%, Octocrylene 8%

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

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 if

Stop use and as 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

■ 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

Other information

■ protect this product from excessive heat and direct sun

■ may stain or damage some fabrics or surfaces

Inactive ingredients

Inactive ingredients water, aluminum starch octenylsuccinate, styrene/acrylates copolymer, glycerin, polyester-27, silica, phenoxyethanol, isododecane, arachidyl alcohol, beeswax, ethylhexylglycerin, neopentyl glycol diheptanoate, acrylates/C10-30 alkyl acrylate crosspolymer, behenyl alcohol, tocopherol, arachidyl glucoside, glyceryl stearate, PEG-100 stearate, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate, fragrance

Questions

Questions? 1-866-288-3330

Package label

New &

Improved

Formula

Coppertone®

SUNSCREEN LOTION

water

babies®

Non-Irritating

Gentle Formula 50

Water Resistant

(80 Minutes)

Broad Spectrum

SPF 50

#1

Pediatrician

Recommended

Brand

INGREDIENTS AND APPEARANCE

COPPERTONE WATER BABIES SPF 50 
avobenzone, homosalate, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7419
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	46.2 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	102.8 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	82.2 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30.8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TOCOPHEROL (UNII: R0ZB2556P8)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
PEG-100 STEARATE (UNII: YD01N1999R)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
ISODODECANE (UNII: A8289P68Y2)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-7419-1	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2017	09/01/2021

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

Labeler - Bayer HealthCare LLC. (112117283)