Coppertone ® water BABIES ® Foaming Lotion SPF 70+

Drug Labeling and Warnings

Drug Details [pdf]

COPPERTONE WATER BABIES SPF 70 PLUS- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone aerosol, foam 
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 ® water BABIES ®







Foaming Lotion SPF 70+

Drug Facts

Active ingredients

(To Deliver) Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%, Oxybenzone 6%

Purpose

Sunscreen

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

For external use only

Flammable

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

Do not use on damaged or broken skin

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 rash occurs

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

Directions

• shake well before 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

• may stain or damage some fabrics or surfaces
• store between 20° to 25°C (68° to 77°F)
• protect this product from excessive heat and direct sun

Inactive ingredients

Water, Isobutane, Sorbitol, Styrene/Acrylates Copolymer, VP/Eicosene Copolymer, Stearic Acid, Benzyl Alcohol, Triethanolamine, Dimethicone, Sorbitan Isostearate, Tocopherol (Vitamin E), Chlorphenesin, Aloe Barbadensis Leaf Extract, Polyglyceryl-3 Distearate, Ethylhexyl Palmitate, Sodium Ascorbyl Phosphate, Retinyl Palmitate (Vitamin A Palmitate), Fragrance, Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Disodium EDTA.

PRINCIPAL DISPLAY PANEL - 170 g Can Label

Foaming

LOTION

Coppertone ®

SUNSCREEN

water

BABIES ®

Foaming

LOTION

Broad

Spectrum

SPF

70 +

#1 PEDIATRICIAN

RECOMMENDED BRAND

Water Resistant

(80 minutes)

70 +

NET WT 6 OZ (170 g)

COPPERTONE WATER BABIES  SPF 70 PLUS
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7363
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	31.2 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	156 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	52 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	104 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	62.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOBUTANE (UNII: BXR49TP611)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TROLAMINE (UNII: 9O3K93S3TK)
DIMETHICONE (UNII: 92RU3N3Y1O)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
CHLORPHENESIN (UNII: I670DAL4SZ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
EDETATE DISODIUM (UNII: 7FLD91C86K)

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: 11523-7363-1	170 g in 1 CAN; Type 0: Not a Combination Product	02/01/2014	08/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/01/2014	08/01/2019

Labeler - Bayer HealthCare LLC. (112117283)

Revised: 7/2017

Document Id: 544a4d24-3156-1719-e054-00144ff88e88

34390-5

Set id: 48405bd6-bf83-4775-8b69-fa3a5dcf99bc

Version: 4

Effective Time: 20170714