Coppertone Sport Spray SPF 15 Spray

Drug Labeling and Warnings

Drug Details [pdf]

COPPERTONE SPORT SPF 15- coppertone sport spray 
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 Spray SPF 15 Spray

Drug Facts

Drug Facts

Active ingredients

Active ingedients

Avobenzone 2%, Ocitsalate 4.5%, Octocrylene 7%

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

Flammable: Do not use near heat, flame, or while smoking

Do Not Use

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

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
• 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
• 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 witha 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
• avoid long term storage above 40°C (104°F)
• may stain or damage some fabrics or surfaces

Inactive ingedients

Inactive ingredients

SD Alcohol 40-B (83.2% v/v), Neopentyl Glycol Diheptanoate, Dimethicone, Polyester-27, Tocopherol (Vitamin E), Fragrance

Questions?

Questions? 1-866-288-3330

COPPERTONE SPORT  SPF 15
coppertone sport spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7385
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	16.52 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	37.17 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	57.82 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
TOCOPHEROL (UNII: R0ZB2556P8)

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: 11523-7385-1	177 mL in 1 CAN; Type 0: Not a Combination Product	11/15/2015	08/07/2019
2	NDC: 11523-7385-2	222 mL in 1 CAN; Type 0: Not a Combination Product	11/15/2015	08/07/2019
3	NDC: 11523-7385-3	237 mL in 1 CAN; Type 0: Not a Combination Product	11/15/2015	08/07/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/15/2015	08/07/2019

Labeler - Bayer HealthCare LLC. (112117283)

Revised: 8/2019

Document Id: 8f89a40f-a259-610f-e053-2a95a90ac727

34390-5

Set id: 280f5603-a959-2702-e054-00144ff88e88

Version: 4

Effective Time: 20190807