OTC Medication Information: Coppertone Defend and Clear

COPPERTONE DEFEND AND CLEAR- zinc oxide, octinoxate and octisalate lotion
Beiersdorf Inc

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.

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)

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 9.7 g in 100 g OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 g in 100 g OCTISALATE (OCTISALATE) OCTISALATE 4.5 g in 100 g

Inactive Ingredients Ingredient Name Strength AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER BENZYL ALCOHOL GLYCERYL STEARATE SE TRIETHOXYCAPRYLYLSILANE CHLORPHENESIN CETOSTEARYL ALCOHOL WATER STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) TRILAURETH-4 PHOSPHATE SYNTHETIC BEESWAX DIMETHICONE MAGNESIUM DISODIUM EDTA GLYCERIN DICAPRYLYL ETHER POLYESTER-7

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:66800-3641-3 88 g in 1 TUBE None 2 NDC:66800-3641-6 177 g in 1 TUBE None

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)

Revised: 02/2023 Beiersdorf Inc