COPPERTONE SPORT SPF 50- coppertone sport lotion

Coppertone Sport by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Drug Facts

Active Ingredients

Active ingredients Purpose

Avobenzone 3%, Homosalate 10%, Octisalate 4.5%, Octocrylene 8%, .....................................Sunscreen

Purpose

Sunscreen

Uses

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

Do Not Use

Do not use on damaged or broken skin

As a doctor before use if you have

Stop use and ask a doctor if rash occurs

When using this product

When using this product keep out of eyes. Rinse with water to remove

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
• reappy

· 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

Inactive Ingredients Water, Aluminum Starch Octenylsuccinate, Styrene/Acrylates Copolymer Glycerin, Polyester-27, Silica, , Phenoxyethanol, Isododecane, Arachidyl Alchohol, Beeswax, Ethylthexlglycerin, Neopentyl Glycol Diheptanoate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Behenyl Alcohol, Tocopherol (Vitamin E), Arachidyl Glucoside, Glyceryl Stearate, PEG 100 Stearate, Potassium Hydroxide, Disodium EDTA, Sodium Ascorbyl Phosphate, Fragrance

Questions or comments

Questions 1-866-288-3330

3 oz. label

New Look

Coppertone®

SUNSCREEN LOTION

Sport™

Stays on

Strong When

You Sweat 50

Water Resistant

(80 Minutes)

Broad Spectrum SPF 50

3 fl oz (89 mL)

INGREDIENTS AND APPEARANCE

COPPERTONE SPORT  SPF 50
coppertone sport lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7395
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30.84 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	102 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	46.26 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	82.24 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ISODODECANE (UNII: A8289P68Y2)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TOCOPHEROL (UNII: R0ZB2556P8)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)

Product Characteristics
Color	white (White to Light Yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-7395-1	89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2015	09/01/2020
2	NDC: 11523-7395-2	207 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2015	09/01/2020
3	NDC: 11523-7395-3	259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2015	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/01/2015	09/01/2020

Labeler - Bayer HealthCare LLC. (112117283)