COPPERTONE DEFEND AND CLEAR- octinoxate, octisalate, zinc oxide lotion

Coppertone Defend and Clear by

Drug Labeling and Warnings

Coppertone Defend and Clear 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

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

Purpose

Sunscreen

Use

helps prevent sunburn

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

■ 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

■ protect this product from excessive heat and direct sun

■ may stain or damage some fabrics or surfaces

Inactive ingredients

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

Questions?

1-866-288-3330

Principal Display Panel

Coppertone Sunscreen Lotion

Clear Zince FACE

with Zinc Oxide

Defend & Care

Lightweight No White Residue

Free of oxybenzone, dyes & PABA

Water Resistant (80 Minutes)

Broad Specturm SPF 50

3 FL OZ (88 mL)

INGREDIENTS AND APPEARANCE

COPPERTONE DEFEND AND CLEAR 
octinoxate, octisalate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66800-3641
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9.7 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
BENZYL ALCOHOL (UNII: LKG8494WBH)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
WATER (UNII: 059QF0KO0R)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)
SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
DIMETHICONE (UNII: 92RU3N3Y1O)
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)
GLYCERIN (UNII: PDC6A3C0OX)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
POLYESTER-7 (UNII: 0841698D2F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66800-3641-3	88 g in 1 TUBE; Type 0: Not a Combination Product	11/02/2020
2	NDC: 66800-3641-6	177 g in 1 TUBE; 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)