LIGHT SKIN DEFENSE CONCEALER BROAD SPECTRUM SPF 15 JAFRA- octinoxate, octisalate, oxybenzone cream MEDIUM SKIN DEFENSE CONCEALER BROAD SPECTRUM SPF 15 JAFRA- octinoxate, octisalate, oxybenzone cream DARK SKIN DEFENSE CONCEALER BROAD SPECTRUM SPF 15 JAFRA- octinoxate, octisalate, oxybenzone cream

Dark Skin Defense Concealer Broad Spectrum SPF 15 by

Drug Labeling and Warnings

Dark Skin Defense Concealer Broad Spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by Jafra Cosmetics International Inc, Distribuidora Comercial Jafra, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients       Purpose

Octinoxate 7%                Sunscreen

Octisalate 3%                 Sunscreen

Oxybenzone 2%             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 product keep out of eyes. Rinse with water to remove.

Directions
   Apply liberally 15 minutes before sun exposure
   Reapply at least every 2 hours
   Use a water resistant sunscreen if swimming or sweating
   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 broad spectrum SPF 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, Butylene Glycol, Glyceryl Stearate, Stearic Acid, Isopropyl Isostearate, Di-PPG-3 Myristyl Ether Adipate, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Cetyl Alcohol, Triethanolamine, Lecithin, Silica, Dimethicone, Polysorbate 20, Hydrolyzed Lupinus Albus (Lupine) Protein, Medicago Sativa (Alfalfa) Seed Extract, DMDM Hydantoin, Xanthan Gum, Biosaccharide Gum-4, Chondrus Crispus (Carrageenan) Extract, Magnesium Aluminum Silicate, Tocopheryl Acetate, Tagetus Erecta (African Marigold) Extract, Ipomoea Batatas Tuber Extract, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Trisodium EDTA [May Contain +/- : Titanium Dioxide/CI 77891, Iron Oxides/CI 77491/CI 77492/CI 77499]

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIGHT SKIN DEFENSE CONCEALER BROAD SPECTRUM SPF 15  JAFRA
octinoxate, octisalate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-170
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
CETYL ALCOHOL (UNII: 936JST6JCN)
TROLAMINE (UNII: 9O3K93S3TK)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALFALFA SEED (UNII: 67PHZ58858)
DMDM HYDANTOIN (UNII: BYR0546TOW)
XANTHAN GUM (UNII: TTV12P4NEE)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SWEET POTATO (UNII: M9WGG9Z9GK)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
EDETATE TRISODIUM (UNII: 420IP921MB)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-170-02	1 in 1 CARTON	05/22/2013
1	NDC: 68828-170-01	15 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	05/22/2013

MEDIUM SKIN DEFENSE CONCEALER BROAD SPECTRUM SPF 15  JAFRA
octinoxate, octisalate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-171
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
CETYL ALCOHOL (UNII: 936JST6JCN)
TROLAMINE (UNII: 9O3K93S3TK)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALFALFA SEED (UNII: 67PHZ58858)
DMDM HYDANTOIN (UNII: BYR0546TOW)
XANTHAN GUM (UNII: TTV12P4NEE)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SWEET POTATO (UNII: M9WGG9Z9GK)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
EDETATE TRISODIUM (UNII: 420IP921MB)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-171-02	1 in 1 CARTON	05/22/2013
1	NDC: 68828-171-01	15 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	05/22/2013

DARK SKIN DEFENSE CONCEALER BROAD SPECTRUM SPF 15  JAFRA
octinoxate, octisalate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-172
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
CETYL ALCOHOL (UNII: 936JST6JCN)
TROLAMINE (UNII: 9O3K93S3TK)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ALFALFA SEED (UNII: 67PHZ58858)
DMDM HYDANTOIN (UNII: BYR0546TOW)
XANTHAN GUM (UNII: TTV12P4NEE)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SWEET POTATO (UNII: M9WGG9Z9GK)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
EDETATE TRISODIUM (UNII: 420IP921MB)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-172-02	1 in 1 CARTON	05/22/2013
1	NDC: 68828-172-01	15 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	05/22/2013

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(68828-170, 68828-171, 68828-172)