Coppertone ® Sport ® SPF 75 Lotion

Drug Labeling and Warnings

Drug Details [pdf]

COPPERTONE SPORT SPF 75- 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 ® Sport ®

SPF 75 Lotion

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
MSD Consumer Care, Inc.,
PO Box 377,
Memphis, TN 38151 USA,
a subsidiary of Merck & Co., Inc.,
Whitehouse Station, NJ USA.

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

Coppertone ®
SPORT ®
High Performance

Sunscreen
UVA/UVB

Broad
Spectrum
SPF
75

Stays on Strong
when you Sweat
(won't run into eyes and sting)

Plus Antioxidant Defense

Water Resistant (80 Minutes)

75

6 FL OZ (177 mL)

38752-FB

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label
COPPERTONE SPORT  SPF 75
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11523-7364
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)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
TROLAMINE (UNII: 9O3K93S3TK)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
OLETH-3 (UNII: BQZ26235UC)  
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: 11523-7364-1177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/201408/07/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/01/201408/07/2019
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 8/2019
Document Id: 8f8959a6-074f-0cef-e053-2995a90a0e40
Set id: 4a8b175d-735d-4e1e-9058-1b3166caf684
Version: 3
Effective Time: 20190807
 
Bayer HealthCare LLC.