NATURAL TAN MOISTURIZING MAKEUP BROAD SPECTRUM SPF 15 JAFRA- octinoxate, octisalate, oxybenzone liquid IVORY MOISTURIZING MAKEUP BROAD SPECTRUM SPF 15 JAFRA- octinoxate, octisalate, oxybenzone liquid BARELY BEIGE MOISTURIZING MAKEUP BROAD SPECTRUM SPF 15 JAFRA- octinoxate, octisalate, oxybenzone liquid CASHMERE MOISTURIZING MAKEUP BROAD SPECTRUM SPF 15 JAFRA- octinoxate, octisalate, oxybenzone liquid

Cashmere Moisturizing Makeup Broad Spectrum SPF 15 by

Drug Labeling and Warnings

Cashmere Moisturizing Makeup Broad Spectrum 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 6%       Sunscreen

Octisalate 3%        Sunscreen

Oxybenzone 2%    Sunscreen 

Uses

helps prevent sunburn

if used as directed with other with other sun protection measures (see Directions), decreases the risk of 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

 -Use a water resistant sunscreen if swimming or 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 skincancer 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

Water/Aqua, Butylene Glycol, Isopropyl Palmitate, Isopropyl Isostearate, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Silica, Di-PPG-3 Myristyl Ether, Glyceryl Stearate, Stearic Acid, Saccharide Isomerate, Polysorbate 20, Lecithin, Butyrospermum Parkii (Shea Butter) Fruit, Polysilicone-11, Laureth-12, Cyclopentasiloxane, Acrylates/Dimethicone Copolymer Methylsilanol Manuuronate DMDM Hydantoin, Trihydroxystearin, Magnesium Aluminum Stearate, Xanthan Gum, Ipomoea Digitata (Fingerleaf Morning Glory) Extract, Withania Somnifera (Winter Cherry) Extract, Vigna Radiata (Mung Bean) Extract, Panthenol, Tocopheryl Acetate, Fragrance/Parfum, Trisodium, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Borago Officinalis Extract, Caldenula Officinalis Flower Extract, Algae Extract, Simmondsia Chinensis (Jojoba) Seed Oil

PRINCIPAL DISPLAY PANEL

Jafra Moisturizing Makeup Broad Spectrum SPF 15

Cont. Net. 30 ml 1Fl Oz (US)

INGREDIENTS AND APPEARANCE

NATURAL TAN MOISTURIZING MAKEUP BROAD SPECTRUM SPF 15  JAFRA
octinoxate, octisalate, oxybenzone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-142
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 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)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SHEA BUTTER (UNII: K49155WL9Y)
LAURETH-12 (UNII: OAH19558U1)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DMDM HYDANTOIN (UNII: BYR0546TOW)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
XANTHAN GUM (UNII: TTV12P4NEE)
MUNG BEAN (UNII: 1LIB31N73G)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE TRISODIUM (UNII: 420IP921MB)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
BORAGE (UNII: PB618V0K2W)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-142-02	1 in 1 CARTON	04/23/2013
1	NDC: 68828-142-01	30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68828-142-04	1 in 1 CARTON	04/23/2013
2	NDC: 68828-142-03	8 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	04/23/2013

IVORY MOISTURIZING MAKEUP BROAD SPECTRUM SPF 15  JAFRA
octinoxate, octisalate, oxybenzone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-143
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 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)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SHEA BUTTER (UNII: K49155WL9Y)
LAURETH-12 (UNII: OAH19558U1)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DMDM HYDANTOIN (UNII: BYR0546TOW)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
XANTHAN GUM (UNII: TTV12P4NEE)
MUNG BEAN (UNII: 1LIB31N73G)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE TRISODIUM (UNII: 420IP921MB)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
BORAGE (UNII: PB618V0K2W)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-143-02	1 in 1 CARTON	04/23/2013
1	NDC: 68828-143-01	30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68828-143-04	1 in 1 CARTON	04/23/2013
2	NDC: 68828-143-03	8 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	04/23/2013

BARELY BEIGE MOISTURIZING MAKEUP BROAD SPECTRUM SPF 15  JAFRA
octinoxate, octisalate, oxybenzone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-144
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 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)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SHEA BUTTER (UNII: K49155WL9Y)
LAURETH-12 (UNII: OAH19558U1)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DMDM HYDANTOIN (UNII: BYR0546TOW)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
XANTHAN GUM (UNII: TTV12P4NEE)
MUNG BEAN (UNII: 1LIB31N73G)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE TRISODIUM (UNII: 420IP921MB)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
BORAGE (UNII: PB618V0K2W)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-144-02	1 in 1 CARTON	04/23/2013
1	NDC: 68828-144-01	30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68828-144-04	1 in 1 CARTON	04/23/2013
2	NDC: 68828-144-03	8 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	04/23/2013

CASHMERE MOISTURIZING MAKEUP BROAD SPECTRUM SPF 15  JAFRA
octinoxate, octisalate, oxybenzone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-145
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6 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)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
STEARIC ACID (UNII: 4ELV7Z65AP)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SHEA BUTTER (UNII: K49155WL9Y)
LAURETH-12 (UNII: OAH19558U1)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DMDM HYDANTOIN (UNII: BYR0546TOW)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
XANTHAN GUM (UNII: TTV12P4NEE)
MUNG BEAN (UNII: 1LIB31N73G)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE TRISODIUM (UNII: 420IP921MB)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
BORAGE (UNII: PB618V0K2W)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-145-02	1 in 1 CARTON	04/23/2013
1	NDC: 68828-145-01	30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68828-145-04	1 in 1 CARTON	04/23/2013
2	NDC: 68828-145-03	8 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	04/23/2013

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(68828-142, 68828-143, 68828-144, 68828-145)