COPPERTONE DEFEND AND CARE FACE SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, octocrylene, oxybenzone stick
Bayer HealthCare LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Coppertone Defend & Care Face Sunscreen Stick SPF 50

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%, Oxybenzone 6%

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

Warnings
For external use only

Do not use

Do not use on damaged or broken skin

When using this product

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

Stop use and ask a doctor

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

■ 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

Inactive ingredients ozokerite, lauryl laurate, tapioca starch, beeswax, behenyl alcohol, caprylic/capric triglyceride, C12-15 alkyl benzoate, silica, synthetic beeswax, tocopherol, aloe barbadensis leaf extract, polymethylsilsesquioxane, calendula officinalis flower extract, cucumis sativus (cucumber) fruit extract, fragrance

Questions

Questions? 1-866-288-3330

Package Display Label

New

Coppertone

Sunscreen Stick

Defend

& Care

Face 50

Antioxidant Enriched

Water Resistant (80 Minutes)

Broad Spectrum

SPF 50

label 2

COPPERTONE DEFEND AND CARE FACE SUNSCREEN SPF 50
avobenzone, homosalate, octisalate, octocrylene, oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11523-7412
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	58.8 mg in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	29.4 mg in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	147 mg in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	49 mg in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	98 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
LAURYL LAURATE (UNII: GPW77G0937)
STARCH, TAPIOCA (UNII: 24SC3U704I)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TOCOPHEROL (UNII: R0ZB2556P8)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CUCUMIS SATIVUS LEAF (UNII: Q6S42514LP)

Product Characteristics
Color	white (Off white to light yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11523-7412-1	1 in 1 BLISTER PACK	11/01/2017	08/01/2021
1		7.09 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	11/01/2017	08/01/2021

Labeler - Bayer HealthCare LLC. (112117283)

Revised: 7/2019

Document Id: 8ed6d504-dace-6446-e053-2a95a90a915c

Set id: 5d30f078-341f-46af-e053-2a91aa0ab9ab

Version: 2

Effective Time: 20190729

Bayer HealthCare LLC.