COPPERTONE SPORT SPF 50 SUNSCREEN- avobenzone 3%, homosalate 10%, octisalate 5%, octocrylene 5% aerosol

Coppertone Sport SPF 50 Sunscreen by

Drug Labeling and Warnings

Coppertone Sport SPF 50 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Beiersdort Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 10%, 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

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

DO NOT USE

Do not use on damaged or broken skin

WHEN USING

When using this product
■ keep away from face to avoid breathing it

■ 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

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

■ spray liberally and spread evenly by hand 15 minutes before sun exposure

■ hold container 4 to 6 inches from the skin to apply

■ do not spray directly into face. Spray on hands then apply to face.

■ do not apply in windy conditions

■ use in a well-ventilated area

■ 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

■ avoid long-term storage above 40˚C (104˚F)

■ may stain or damage some fabrics or surfaces

Inactive ingredients

SD alcohol 40-B (73.9% v/v), neopentyl glycol diheptanoate, polyester-27, acrylates/octylacrylamide copolymer, dimethicone, fragrance, ascorbyl palmitate

Questions

1-866-288-3330

PRINCIPAL DISPLAY PANEL

Coppertone® Sunscreen Spray

Sport 50

Stays on Strong When You Sweat

No Dyes, PABA, Oxybenzone

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

Net Wt 5.5 OZ (156 g)

INGREDIENTS AND APPEARANCE

COPPERTONE SPORT SPF 50 SUNSCREEN 
avobenzone 3%, homosalate 10%, octisalate 5%, octocrylene 5% aerosol

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66800-4355
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYESTER-7 (UNII: 0841698D2F)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)
ASCORBYL PALMITATE (UNII: QN83US2B0N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66800-4355-5	156 g in 1 CAN; Type 0: Not a Combination Product	11/03/2020
2	NDC: 66800-4355-6	196 g in 1 CAN; Type 0: Not a Combination Product	11/03/2020
3	NDC: 66800-4355-7	208 g in 1 CAN; Type 0: Not a Combination Product	11/03/2020
4	NDC: 66800-4355-8	235 g in 1 CAN; Type 0: Not a Combination Product	11/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/03/2020

Labeler - Beiersdort Inc (001177906)