COPPERTONE TANNING DRY OIL SPF 10- homosalate, octinoxate, octisalate, and oxybenzone spray

Coppertone Tanning Dry Oil by

Drug Labeling and Warnings

Coppertone Tanning Dry Oil 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

Homosalate 5%, Octinoxate 7.5%, Octisalate 5% and Oxybenzone 3%

Purpose

Sunscreen

Use

helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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
• 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

alcohol denat. (80.6% V/V), acrylates/octylacrylamide copolymer, mineral oil, fragrance

Questions?

866-288-3330

PRINCIPAL DISPLAY PANEL - 177 mL Can Label

INGREDIENTS AND APPEARANCE

COPPERTONE TANNING DRY OIL  SPF 10
homosalate, octinoxate, octisalate, and oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7216
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	42.2 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	63.3 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	42.2 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	25.32 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)

Product Characteristics
Color	yellow (clear to pale yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-7216-1	177 mL in 1 CAN; Type 0: Not a Combination Product	02/01/2012	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2012	09/01/2020

Labeler - Bayer HealthCare LLC. (112117283)