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

Barely Beige Oil Controlling Makeup Broad Spectrum SPF 15 by

Drug Labeling and Warnings

Barely Beige Oil Controlling 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 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
- 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 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, Isopropyl Palmitate, Isopropyl Isostearate, Potassium Cetyl Phosphate, Hydrogenated Palm Glcyerides, Glyceryl Stearate, Di-PPG-3 Myristyl Ether Adipate, Silica, Stearic Acid, Zinc Oxide/CI 77947, Polysorbate 20, Lecithin, Polysilicone-11, Laureth-12, Cyclopentasiloxane, Acrylates/Dimethicone Copolymer, DMDM Hydantoin, Trihydroxystearin, Magnesium Aluminum Silicate, Xanthan Gum, Panthenol, Ipomoea Digitata (Fingerleaf Morning Glory) Extract, Withania Somnifera (Winter Cherry) Extract, Vigna Radiata (Mung Bean) Extract, Tocopheryl Acetate, Hamamelis Virginia (Witch Hazel) Extract, Symphytum Officinale Leaf Extract, Chamomilla Recitita (Matricaria) Flower Extract, Cucumis Sativas (Cucumber) Fruit Extract, Aloe Barbadensis Leaf Extract, Althaea Officinalis Root Extract Root Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Fragrance/Parfum, Trisodium EDTA, PEG-4 Laurate, Iodopropynyl Butylcarbamate.

PRINCIPAL DISPLAY PANEL

Jafra
Oil Controlling Makeup
Broad Spectrum SPF 15
Cont. Net. 30 ml 1 Fl Oz

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-139
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)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
ZINC OXIDE (UNII: SOI2LOH54Z)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
LAURETH-12 (UNII: OAH19558U1)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DMDM HYDANTOIN (UNII: BYR0546TOW)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
XANTHAN GUM (UNII: TTV12P4NEE)
PANTHENOL (UNII: WV9CM0O67Z)
MUNG BEAN (UNII: 1LIB31N73G)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
COMFREY LEAF (UNII: DG4F8T839X)
CHAMOMILE (UNII: FGL3685T2X)
CUCUMBER (UNII: YY7C30VXJT)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TEA TREE OIL (UNII: VIF565UC2G)
EDETATE TRISODIUM (UNII: 420IP921MB)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-139-02	1 in 1 CARTON	04/19/2013
1	NDC: 68828-139-01	30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68828-139-04	10 in 1 CARTON	04/19/2013
2	NDC: 68828-139-03	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	04/19/2013

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-140
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)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
ZINC OXIDE (UNII: SOI2LOH54Z)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
LAURETH-12 (UNII: OAH19558U1)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DMDM HYDANTOIN (UNII: BYR0546TOW)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
XANTHAN GUM (UNII: TTV12P4NEE)
PANTHENOL (UNII: WV9CM0O67Z)
MUNG BEAN (UNII: 1LIB31N73G)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
COMFREY LEAF (UNII: DG4F8T839X)
CHAMOMILE (UNII: FGL3685T2X)
CUCUMBER (UNII: YY7C30VXJT)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TEA TREE OIL (UNII: VIF565UC2G)
EDETATE TRISODIUM (UNII: 420IP921MB)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-140-02	1 in 1 CARTON	04/19/2013
1	NDC: 68828-140-01	30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68828-140-04	10 in 1 CARTON	04/19/2013
2	NDC: 68828-140-03	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	04/19/2013

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-141
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)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
ZINC OXIDE (UNII: SOI2LOH54Z)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
LAURETH-12 (UNII: OAH19558U1)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DMDM HYDANTOIN (UNII: BYR0546TOW)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
XANTHAN GUM (UNII: TTV12P4NEE)
PANTHENOL (UNII: WV9CM0O67Z)
MUNG BEAN (UNII: 1LIB31N73G)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
COMFREY LEAF (UNII: DG4F8T839X)
CHAMOMILE (UNII: FGL3685T2X)
CUCUMBER (UNII: YY7C30VXJT)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TEA TREE OIL (UNII: VIF565UC2G)
EDETATE TRISODIUM (UNII: 420IP921MB)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-141-02	1 in 1 CARTON	04/19/2013
1	NDC: 68828-141-01	30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68828-141-04	10 in 1 CARTON	04/19/2013
2	NDC: 68828-141-03	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	04/19/2013

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(68828-139, 68828-140, 68828-141)