COPPERTONE SPORT SPF 50- coppertone sport 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 Sport SPF 50 Lotion UI 1612670

Drug Facts

Drug Facts

Active Ingredients

Active ingredients Purpose

Avobenzone 3%, Homosalate 10%, Octisalate 4.5%, Octocrylene 8%, .....................................Sunscreen

Purpose

Sunscreen

Uses

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

Do Not Use

Do not use on damaged or broken skin

As a doctor before use if you have

Stop use and ask a doctor if rash occurs

When using this product

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

Stop use and ask a doctor if

Stop use and ask a doctor if rash occurs

Keep out of reach of children

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
  • reappy

· 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

Inactive Ingredients Water, Aluminum Starch Octenylsuccinate, Styrene/Acrylates Copolymer Glycerin, Polyester-27, Silica, , Phenoxyethanol, Isododecane, Arachidyl Alchohol, Beeswax, Ethylthexlglycerin, Neopentyl Glycol Diheptanoate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Behenyl Alcohol, Tocopherol (Vitamin E), Arachidyl Glucoside, Glyceryl Stearate, PEG 100 Stearate, Potassium Hydroxide, Disodium EDTA, Sodium Ascorbyl Phosphate, Fragrance

Questions or comments

Questions 1-866-288-3330

3 oz. label

New Look

Coppertone®

SUNSCREEN LOTION

Sport™

Stays on

Strong When

You Sweat 50

Water Resistant

(80 Minutes)

Broad Spectrum SPF 50

3 fl oz (89 mL)

front labelback label

COPPERTONE SPORT  SPF 50
coppertone sport lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-7395
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30.84 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE102 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE46.26 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE82.24 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ISODODECANE (UNII: A8289P68Y2)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TOCOPHEROL (UNII: R0ZB2556P8)  
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERIN (UNII: PDC6A3C0OX)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
Product Characteristics
Colorwhite (White to Light Yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-7395-189 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/201509/01/2020
2NDC:11523-7395-2207 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/201509/01/2020
3NDC:11523-7395-3259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/01/201509/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/01/201509/01/2020
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 8/2019
 
Bayer HealthCare LLC.