COPPERTONE LIMITED EDITION SUNSCREEN SPF 50- avobenzone 3%, homosalate 10%, octisalate 5%, octocrylene 5% aerosol, spray

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

(To Deliver) 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.

■ use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

■ 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

■ shake well before each use

■ 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

■ store between 20˚ to 25˚C (68˚ to 77˚F)

■ may stain or damage some fabrics or surfaces

Inactive ingredients

SD alcohol 40-B (73.8% v/v), isobutane, neopentyl glycol dipheptanoate, polyester-27, acrylates/octylacrylamide copolymer, dimethicone, fragrance, ascorbyl palmitate

Questions?

1-866-288-3330

PRINCIPAL DISPLAY PANEL

Limited Edition

Coppertone ® Sunscreen Spray 50

Protects against damaging UVA/UVB rays

Water Resistant (80 Minutes)

Broad Spectrum SPF 50

NET WT 1.6 OZ (45 g)

INGREDIENTS AND APPEARANCE

COPPERTONE LIMITED EDITION SUNSCREEN SPF 50 
avobenzone 3%, homosalate 10%, octisalate 5%, octocrylene 5% aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66800-4354
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)
ALCOHOL (UNII: 3K9958V90M)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
POLYESTER-7 (UNII: 0841698D2F)
ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)
DIMETHICONE (UNII: 92RU3N3Y1O)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ISOBUTANE (UNII: BXR49TP611)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66800-4354-1	45 g in 1 CAN; Type 0: Not a Combination Product	11/04/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/04/2020

Labeler - Beiersdorf Inc (001177906)