DOUBLE DUTY FACE PROTECTOR SPF 15 JAFRA- octinoxate, octisalate, zinc oxide lotion

Double Duty Face Protector SPF 15 by

Drug Labeling and Warnings

Double Duty Face Protector SPF 15 by is a Otc medication manufactured, distributed, or labeled by Jafra Cosmetics International Inc, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Men Dynamics
Double Duty Face Protector Broad Spectrum SPF 15
with intellishield

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

INGREDIENTS AND APPEARANCE

DOUBLE DUTY FACE PROTECTOR SPF 15  JAFRA
octinoxate, octisalate, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-161
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TREHALOSE (UNII: B8WCK70T7I)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
UREA (UNII: 8W8T17847W)
MUNG BEAN (UNII: 1LIB31N73G)
DMDM HYDANTOIN (UNII: BYR0546TOW)
EDETATE TRISODIUM (UNII: 420IP921MB)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-161-02	1 in 1 BOX	12/04/2012
1	NDC: 68828-161-01	75 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/04/2012

Labeler - Jafra Cosmetics International Inc (041676479)

Registrant - Jafra Cosmetics International Inc (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture(68828-161)