COPPERTONE SPORT SUNSCREEN LIP BALM SPF 30- avobenzone, octisalate, octocrylene, and oxybenzone stick

Coppertone Sport Sunscreen Lip Balm by

Drug Labeling and Warnings

Coppertone Sport Sunscreen Lip Balm by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone 3%, Octisalate 3%, Octocrylene 9.09%, Oxybenzone 5%

Purpose

Sunscreen

Use

• helps prevent sunburn

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 to lips 15 minutes before sun exposure
• reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
• 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

Petrolatum, Beeswax, Ozokerite, Ricinus Communis (Castor) Seed Oil, Zea Mays (Corn) Oil, Ethylhexyl Palmitate, Euphorbia Cerifera (Candelilla) Wax, Paraffin, Stearyl Alcohol, Phenoxyethanol

Questions?

866-288-3330

PRINCIPAL DISPLAY PANEL - 4.2 g Tube Label

Coppertone®

SPORT®

Sunscreen Lip Balm

Broad

Spectrum

SPF

30

NET WT

.15 OZ (4.2 g)

38672-00

INGREDIENTS AND APPEARANCE

COPPERTONE SPORT SUNSCREEN LIP BALM  SPF 30
avobenzone, octisalate, octocrylene, and oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7053
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	90.9 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
YELLOW WAX (UNII: 2ZA36H0S2V)
CASTOR OIL (UNII: D5340Y2I9G)
CORN OIL (UNII: 8470G57WFM)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CANDELILLA WAX (UNII: WL0328HX19)
PARAFFIN (UNII: I9O0E3H2ZE)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-7053-1	1 in 1 BLISTER PACK	05/21/1999	09/01/2020
1		4.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/21/1999	09/01/2020

Labeler - Bayer HealthCare LLC. (112117283)