Coppertone ® Wet and Clear ® Kids SPF 50 Plus

Coppertone ® Wet and Clear ® Kids SPF 50 Plus

Drug Labeling and Warnings

Drug Details

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COPPERTONE WET AND CLEAR KIDS  SPF 50 PLUS- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray 
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 ® Wet and Clear ® Kids







SPF 50 Plus

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 10%, Octisalate 4.5%, Octocrylene 9%, Oxybenzone 5%

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.
  • 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

  • apply liberally 15 minutes before sun exposure
  • 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
  • avoid long term storage above 40°C (104°F)
  • protect this product from excessive heat and direct sun

Inactive Ingredients

SD Alcohol 40-B (49.5% V/V), C12-15 Alkyl Benzoate, Octyldodecyl Citrate Crosspolymer, Isohexadecane, Isododecane, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Tocopherol (Vitamin E), Ascorbyl Palmitate, C13-15 Alkane, Fragrance

Questions?

866-288-3330

Wet and Clear Kids SPF 50 carton

COPPERTONE WET AND CLEAR KIDS   SPF 50 PLUS
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11523-7355
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE26.73 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE89.11 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40.1 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE80.2 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE44.56 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
ISODODECANE (UNII: A8289P68Y2)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
C13-15 ALKANE (UNII: 114P5I43UJ)  
Product Characteristics
Coloryellow (Clear, yellow to dark) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11523-7355-2177 mL in 1 CAN; Type 0: Not a Combination Product03/15/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/15/2012
Labeler - Bayer HealthCare LLC. (112117283)
Establishment
NameAddressID/FEIBusiness Operations
Bayer HealthCare LLC968091715manufacture(11523-7355)

Revised: 10/2017
 
Bayer HealthCare LLC.


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