COPPERTONE KIDS SPF 70 PLUS- 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 Kids SPF 70 Lotion UI 1612464

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 13%, 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

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, Butyloctyl Salicylate, Butylene Glycol, Styrene/Acrylates Copolymer, Bis-Stearyl Ethylenediamine/Neopentyl Glycol/Stearyl Hydrogenated Dimer Dilinoleate Copolymer, Benzyl Alcohol, Tocopherol (Vitamin E), Diethylhexyl Syringylidenemalonate, Retinyl Palmitate (Vitamin A Palmitate), Sodium Ascorbyl Phosphate, Triethanolamine, Chlorphenesin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Oleth-3, Fragrance, Disodium EDTA.

Questions?

866-288-3330

Distributed by

2015 Bayer Distributed by Bayer HealthCare LLC

Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

New Look

Coppertone ®
SUNSCREEN LOTION

kids

Stays on

Strong When

Kids Play 70

Water Resistant
(80 minutes)

Broad Spectrum

SPF 70

#1 PEDIATRICIAN
RECOMMENDED BRAND

8 FL OZ (237 mL)

product label

COPPERTONE KIDS  SPF 70 PLUS
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7281
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30.9 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE133.9 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE51.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE103 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE61.8 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
TROLAMINE (UNII: 9O3K93S3TK)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Product Characteristics
Colorwhite (White to yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-7281-1177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/21/199911/01/2017
2NDC:11523-7281-2237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/201708/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/21/199905/01/2021
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 7/2019
Document Id: 8ed76b45-b6d4-4dc1-e053-2a95a90a43a9
Set id: 9a762e4f-e386-435a-b199-014b5521a223
Version: 6
Effective Time: 20190729
 
Bayer HealthCare LLC.