DOUBLE DUTY FACE PROTECTOR SPF 15 JAFRA- octinoxate, octisalate and zinc oxide lotion 
Jafra Cosmetics International 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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Active ingredients Purpose

Octinoxate 7.5% Sunscreen

Octisalate 5% Sunscreen

Zinc Oxide 2.9% 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

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if rash occurs.

Warnings

For external use only

Do not use on damaged or broken skin

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

Directions

apply liberally 15 minutes before sun exposure

use a water resistant sunscreen if swimming ir sweating

reapply at least every 2 hours

children under 6 months: Ask a doctor

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

Inactive Ingredients

Water/Aqua, Polyglyceryl-3 Methylglucose Distearate, Dimethicone, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Glyceryl Stearate, Fragrance/Parfum, Glycerin, Sodium Hyaluronate, Trehalose, Sodium PCA, Polyquaternium-51, Urea, Ipomoea Digitata (Fingerleaf Morning Glory) Extract, Withania Somnifera (Winter Cherry) Extract, Vigna Radiata (Mung Bean) Extract, Galactoarabinan, DMDM Hydantoin, Trisodium EDTA, Panthenol, Tocopheryl Acetate, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Chondrus Crispus (Carrageenan) Extract, Biosaccharide Gum-4

box art

Men Dynamics

Double Duty Face Protector Broad Spectrum SPF 15

with intellishield

Jafra

Cont. Net. 75 ml 2.5 Fl Oz (US)

DOUBLE DUTY FACE PROTECTOR SPF 15  JAFRA
octinoxate, octisalate, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-161
Route of AdministrationtopicalDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5.0 g  in 100 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE2.9 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
DIMETHICONE 
POLYACRYLAMIDE (1500 MW) 
C13-14 ISOPARAFFIN 
LAURETH-7 
GLYCERYL MONOSTEARATE 
GLYCERIN 
HYALURONATE SODIUM 
TREHALOSE 
SODIUM PYRROLIDONE CARBOXYLATE 
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) 
UREA 
MUNG BEAN 
DMDM HYDANTOIN 
EDETATE TRISODIUM 
PANTHENOL 
.ALPHA.-TOCOPHEROL ACETATE 
PEG-4 LAURATE 
IODOPROPYNYL BUTYLCARBAMATE 
CHONDRUS CRISPUS 
Packaging
#Item CodePackage Description
1NDC:68828-161-021 in 1 BOX
1NDC:68828-161-0175 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/04/2012
Labeler - Jafra Cosmetics International Inc (041676479)
Registrant - Jafra Cosmetics International Inc (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-161)

Revised: 12/2012
Document Id: 6b95bbbf-e971-4e31-bf29-22c2a2c468ba
Set id: 62a63a79-7d4c-4d10-ad43-526ffc8a626b
Version: 2
Effective Time: 20121221
 
Jafra Cosmetics International Inc