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

Coppertone Limited Edition Sunscreen SPF 50 by

Drug Labeling and Warnings

Coppertone Limited Edition 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

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
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.

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

■ 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, fragrance, arachidyl glucoside, glyceryl stearate, PEG-100 stearate, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate

Questions?

1-866-288-3330

PRINCIPAL DISPLAY PANEL

Limited Edition

Coppertone ® Sunscreen Lotion

50

Protect against damaging UVA/UVB Rays

Water Resistant (80 Minutes) Broad Spectrum SPF 50

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66800-4079
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
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

Inactive Ingredients
Ingredient Name	Strength
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PEG-100 STEARATE (UNII: YD01N1999R)
WATER (UNII: 059QF0KO0R)
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
POLYESTER-7 (UNII: 0841698D2F)
ISODODECANE (UNII: A8289P68Y2)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
TOCOPHEROL (UNII: R0ZB2556P8)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DOCOSANOL (UNII: 9G1OE216XY)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

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: 66800-4079-8	237 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 not final	part352	11/02/2020

Labeler - Beiersdorf Inc (001177906)