COPPERTONE DEFEND AND CARE FACE CLEAR ZINC SPF 50- octinoxate, octisalate, zinc oxide lotion

Coppertone Defend and Care by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients

Octinoxate 7.5%, Octisalate 4.5%, Zinc Oxide 9.7%

PURPOSE

Purpose

Sunscreen

Use

Use

■ helps prevent sunburn

WARNINGS

Warnings
For external use only

DO NOT USE

Do not use on damaged or broken skin

WHEN USING

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

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.

DOSAGE & ADMINISTRATION

Directions

■ shake well before use

■ 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

Other information

■ protect this product from excessive heat and direct sun

■ may stain or damage some fabrics or surfaces

INACTIVE INGREDIENT

Inactive ingredients water, dicaprylyl ether, glycerin, polyester-27, styrene/acrylates copolymer, trilaureth-4 phosphate, cetearyl alcohol, beeswax, dimethicone, ammonium acryloyldimethyltaurate/vp copolymer, benzyl alcohol, glyceryl stearate, triethoxycaprylylsilane, chlorphenesin, disodium EDTA

QUESTIONS

Questions? 1-866-288-3330

Package Display Panel

New

Coppertone®

Sunscreen Lotion

Defend

& Care™

Clear

Zinc 50

Advanced

Invisible Protection

Water Resistant (80 minutes)

Broad Spectrum SPF 50

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COPPERTONE DEFEND AND CARE  FACE CLEAR ZINC SPF 50
octinoxate, octisalate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-7413
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	79.5 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	47.7 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	102.8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
DIMETHICONE (UNII: 92RU3N3Y1O)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHLORPHENESIN (UNII: I670DAL4SZ)
WATER (UNII: 059QF0KO0R)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-7413-2	88 mL in 1 TUBE; Type 0: Not a Combination Product	11/01/2017	11/01/2021
2	NDC: 11523-7413-3	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2017	11/01/2021

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

Labeler - Bayer HealthCare LLC. (112117283)