COPPERTONE WATER BABIES PURE AND SIMPLE WHIPPED SPF 50- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Coppertone Water Babies Pure And Simple Whipped by

Drug Labeling and Warnings

Coppertone Water Babies Pure And Simple Whipped 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

(To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 4.5%,

Octocrylene 4%, Oxybenzone 6%

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 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 as a doctor

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

apply liberally 15 minutes before sun exposure

do not dispense or apply directly on face. Dispense 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 and higher and other sun protection measures including:

• limit time in the sun, expecially from 10 a.m.-2 p.m.
• wear long-sleeve shirts, pant, hats, and sunglasses

children under 6 months: Ask a doctor

Other information

Other information

• protect this product from excessive heat and direct sun
• avoid long term storage above 40°C (104°F)
• may stain or damage some fabrics or surfaces

Inactive Ingredients

Inactive Ingredients Water, Aluminum Starch Octenylsuccinate, Behenyl Alcohol, Glycerin, Styrene/Acrylates Copolymer, Dicaprylyl Ether, Microcrystalline Cellulose, Glyceryl Stearate, Cetyl Alcohol, Benzyl Alcohol, Butylated PVP, Palmitic Acid, Stearic Acid, Myristyl Alcohol, Chlorphenesin, Tocopherol (Vitamin E), Cellulose Gum, Lecithin, Disodium EDTA, Lauryl Alcohol, Sodium Ascorbyl Phosphate, Nitrous Oxide.

Questions?

Questions? 1-866-288-3330

Package display

New Look

Coppertone®

SUNSCREEN

water

babies™

Pure & Simple

Whipped

No Fragrance

Parabens, PABA 50

Water Resistant

(80 Minutes)

Broad Spectrum

SPF 50

#1

Pediatrician

Recommended

Brand

INGREDIENTS AND APPEARANCE

COPPERTONE WATER BABIES PURE AND SIMPLE WHIPPED  SPF 50
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7403
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
GLYCERIN (UNII: PDC6A3C0OX)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
PALMITIC ACID (UNII: 2V16EO95H1)
STEARIC ACID (UNII: 4ELV7Z65AP)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
CETYL ALCOHOL (UNII: 936JST6JCN)
BENZYL ALCOHOL (UNII: LKG8494WBH)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
CHLORPHENESIN (UNII: I670DAL4SZ)
LAURYL ALCOHOL (UNII: 178A96NLP2)
NITROUS OXIDE (UNII: K50XQU1029)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-7403-1	142 g in 1 CAN; Type 0: Not a Combination Product	11/30/2016	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/30/2016	09/01/2020

Labeler - Bayer Healthcare LLC. (112117283)