Coppertone ® Water Babies ® SPF 50

Drug Labeling and Warnings

Drug Details [pdf]

COPPERTONE WATER BABIES SPF 50- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone 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 ® Water Babies ®



SPF 50

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 13%, Octisalate 5%, Octocrylene 7%, Oxybenzone 4%

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

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove

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

• 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

water, sorbitol, aluminum starch octenylsuccinate, VP/eicosene copolymer, stearic acid, triethanolamine, sorbitan isostearate, benzyl alcohol, dimethicone, tocopherol (vitamin E), polyglyceryl-3 distearate, fragrance, methylparaben, carbomer, propylparaben, disodium EDTA

Questions?

866-288-3330

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

Coppertone ®

SUNSCREEN LOTION

water

BABIES ®

Broad

Spectrum

SPF

50

#1 PEDIATRICIAN

RECOMMENDED BRAND

Water Resistant

(80 minutes)

50

8 FL OZ (237 mL)

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7207
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30.9 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	133.9 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	51.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	72.1 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	41.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
BENZYL ALCOHOL (UNII: LKG8494WBH)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-7207-1	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/12/1993	08/01/2019
2	NDC: 11523-7207-2	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/12/1993	08/01/2019
3	NDC: 11523-7207-5	88 mL in 1 TUBE; Type 0: Not a Combination Product	05/12/1993	08/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/12/1993	08/01/2019

Labeler - Bayer HealthCare LLC. (112117283)

Revised: 8/2019

Document Id: 90046950-35fb-a872-e053-2995a90a7257

34390-5

Set id: 12ddcee7-4cbe-4b3c-bc6c-cfcaf03e7b97

Version: 6

Effective Time: 20190813

 

Bayer HealthCare LLC.