COPPERTONE SUNSCREEN SPF 50- avobenzone 3%, homosalate 10%, octisalate 4.5%, octocrylene 8% lotion

Coppertone Sunscreen SPF 50 by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredients

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

Purpose

Sunscreen

Use

■ helps prevent sunburn

Warnings

For external use only

DO NOT USE

Do not use on damaged or broken skin

STOP USE

Stop use and ask a doctor if rash occurs

WHEN USING

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

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

■ 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

■ may stain or damage some fabrics or surfaces

Inactive ingredients

water, aluminum starch octenylsuccinate, styrene/acrylates copolymer, glycerin, polyester-27, silica, phenoxyethanol,

isododecane, arachidyl alcohol, beeswax, ethylhexylglycerin, neopentyl glycol

diheptanoate, behenyl alcohol, tocopherol, acrylates/C10-30 alkyl acrylate

crosspolymer, arachidyl glucoside, glyceryl stearate, PEG-100 stearate, potassium

hydroxide, fragrance, disodium EDTA, sodium ascorbyl phosphate

Questions?

1-866-288-3330

PRINCIPAL DISPLAY PANEL

Coppertone ® Suncreen Lotion

Sport 50

4-IN-1 Performance

Stops up to 98% UV Rays

+Resists

Sweat+Heat+Water

Free of Oxybenzone, Octinoxate, PABA, Phthalates & Dyes

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

INGREDIENTS AND APPEARANCE

COPPERTONE SUNSCREEN SPF 50 
avobenzone 3%, homosalate 10%, octisalate 4.5%, octocrylene 8% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66800-4107
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
PEG-20 STEARATE (UNII: NBX892EA57)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
DOCOSANOL (UNII: 9G1OE216XY)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
GLYCERIN (UNII: PDC6A3C0OX)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
WATER (UNII: 059QF0KO0R)
FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)
POLYESTER-7 (UNII: 0841698D2F)
ISODODECANE (UNII: A8289P68Y2)

Product Characteristics
Color	white (white to off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66800-4107-3	89 g in 1 TUBE; Type 0: Not a Combination Product	11/02/2020
2	NDC: 66800-4107-7	207 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/02/2020
3	NDC: 66800-4107-8	259 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/02/2020
4	NDC: 66800-4107-9	269 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/02/2020

Labeler - Beiersdorf Inc (001177906)