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

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D&C Clear Zinc Face SPF 50

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)

DC_Clear Zinc Face

COPPERTONE DEFEND AND CLEAR 
octinoxate, octisalate, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66800-3641
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9.7 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66800-3641-388 g in 1 TUBE; Type 0: Not a Combination Product11/02/2020
2NDC:66800-3641-6177 g in 1 TUBE; Type 0: Not a Combination Product11/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/02/2020
Labeler - Beiersdorf Inc (001177906)

Revised: 2/2023
Document Id: f4d2e84b-f7b5-3fbf-e053-2a95a90a04e7
Set id: baaec6a9-2c60-2d11-e053-2a95a90abca7
Version: 3
Effective Time: 20230216
 
Beiersdorf Inc