Coppertone ® Sport ® SPF 15 Lotion

Drug Labeling and Warnings

Drug Details [pdf]

COPPERTONE SPORT SPF 15- avobenzone, homosalate, octisalate, and octocrylene 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 15 Lotion

Drug Facts

Active ingredients

Avobenzone 2%, Homosalate 8%, Octisalate 5%, Octocrylene 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

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, Propylene Glycol, Ethylhexyl Palmitate, Neopentyl Glycol Diheptanoate, Bis-Stearyl Ethylenediamine/Neopentyl Glycol/Stearyl Hydrogenated Dimer Dilinoleate Copolymer, Benzyl Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Chlorphenesin, Oleth-3, Tocopherol (Vitamin E), 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 - 237 mL Bottle Label

Coppertone ®
SPORT ®
High Performance

Sunscreen
UVA/UVB

Broad
Spectrum
SPF
15

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

Ultra Dry Formula
Water Resistant (80 Minutes)

15

8 FL OZ (237 mL)

38999-FA

COPPERTONE SPORT  SPF 15
avobenzone, homosalate, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-0461
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	19.98 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	79.92 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	49.95 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	49.95 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TROLAMINE (UNII: 9O3K93S3TK)
CHLORPHENESIN (UNII: I670DAL4SZ)
OLETH-3 (UNII: BQZ26235UC)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-0461-2	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/21/1999	08/07/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/21/1999	08/07/2019

Labeler - Bayer HealthCare LLC (112117283)

Revised: 8/2019

Document Id: 8f89a40f-a212-610f-e053-2a95a90ac727

34390-5

Set id: f2448462-1db4-4ce2-86f8-2e4a27b83b5c

Version: 3

Effective Time: 20190807