COPPERTONE KIDS SPF 55- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone stick 
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 55 Stick 1612447

Drug Facts

Active ingredients

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

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

Beeswax, Lauryl Laurate, Ozokerite, Cetearyl Behenate, Polybutene, Cetyl Alcohol, Styrene/Acrylates Copolymer, Myristyl Myristate, Tocopherol (Vitamin E), Theobroma Cacao (Cocoa) Seed Butter, Phenoxyethanol, Retinyl Palmitate (Vitamin A Palmitate),Tetrahexyldecyl Ascorbate

Questions?

866-288-3330

PRINCIPAL DISPLAY PANEL - 17g Blister Pack

New Look

Coppertone ®
SUNSCREEN STICK

kids 55 ®

#1 PEDIATRICIAN
RECOMMENDED
BRAND

Water Resistant
(80 minutes)

55

NET WT 0.6 OZ (17g)

front label

back label

COPPERTONE KIDS  SPF 55
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7306
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE60 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
LAURYL LAURATE (UNII: GPW77G0937)  
CETEARYL BEHENATE (UNII: 7ARI9LTH0U)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
COCOA BUTTER (UNII: 512OYT1CRR)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
Product Characteristics
Colorwhite (White to off-white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-7306-21 in 1 BLISTER PACK07/21/201608/01/2020
1NDC:11523-7306-117 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/21/199908/01/2020
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 7/2019
 
Bayer HealthCare LLC.