COPPERTONE KIDS 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 ® kids

SPF 50 Lotion

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 13%, Octisalate 5%, Octocrylene 5%, 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, Styrene/Acrylates Copolymer, Propylene Glycol, Neopentyl Glycol Diheptanoate, Bis-Stearyl Ethylenediamine/Neopentyl Glycol/Stearyl Hydrogenated Dimer Dilinoleate Copolymer, Benzyl Alcohol, Diethylhexyl Syringylidenemalonate, Tocopherol (Vitamin E), Sodium Ascorbyl Phosphate, Retinyl Palmitate (Vitamin A), Triethanolamine, Chlorphenesin, Fragrance, Oleth-3, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylic/Capric Triglyceride, Disodium EDTA

Questions?

866-288-3330

PRINCIPAL DISPLAY PANEL - 88 mL Tube Label

Coppertone ®

SUNSCREEN LOTION

kids

Broad

Spectrum

SPF

50

#1 PEDIATRICIAN

RECOMMENDED BRAND

Won't Run Into

Eyes And Sting

Water Resistant

(80 minutes)

50

3 FL OZ (88 mL)

3 oz. tube label

COPPERTONE KIDS  SPF 50
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7371
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30.3 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE131.3 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50.5 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE60.6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
TROLAMINE (UNII: 9O3K93S3TK)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
OLETH-3 (UNII: BQZ26235UC)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Product Characteristics
Colorwhite (White to light yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-7371-188 mL in 1 TUBE; Type 0: Not a Combination Product05/21/199908/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35205/21/199908/01/2020
Labeler - Bayer Healthcare LLC (112117283)

Revised: 7/2019
Document Id: 8ed73b06-cd8f-534b-e053-2995a90ab730
Set id: 7466ff6d-899c-4d1b-8bdb-f7759110cf22
Version: 3
Effective Time: 20190729
 
Bayer Healthcare LLC