OIL CONTROL TESTERS SPF 15- octinoxate, octisalate, octocrylene lotion

Oil Control by

Drug Labeling and Warnings

Oil Control by is a Otc medication manufactured, distributed, or labeled by JAFRA COSMETICS INTERNATIONAL, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sunscreen Active ingredient (SPF 15): Octinoxate/Ehtylhexyl Methoxycinnamate, Octisalate/Ethylhexyl Salicylate, Oxybenzone/Benzophenone-3

This information is not included

Keep out of reach of children

Discontinue use if signs of irritation occur

Caution: For external use only. Avoid contact with eyes.

This information is not included.

Other ingredients: Water/Aqua, Butylene Glycol, Isopropyl Palmitate, Isopropyl Isostearate, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Glyceryl Stearate, Di-PPG-3 Myristyl Ether Adipate, Silica, Stearic Acid, Zinc Oxide/CI 77497, Polysorbate 20, Lecithin, Polysilicone-11, Laureth-12, Cyclopentasiloane, Acrylates/Dimthicone Copolymer, DMDM Hydantoin, Trihydroxystearin, Magnesium Aluminum Stearate, Xanthan Gum, Panthenol, Ipomoea Digitata (Fingerleaf Morning Glory) Extract, Withania Somnifera (winter Cherry) Extract, Vigna Radiata (Mung Bean) Extract, Tocopheryl Acetate, Hamaelis Virginia (Witch Hazel) Extract, Symphytum Officinale Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cucumis Sativas (Cucumber) Fruit Extract, Aloe Barbadensis Leaf Extract, Althaea Officinalis Root Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Fragrance/Parfum, Trisodium EDTA, PEG-4 Laurate, Iodoproynyl Butylcarbamate [May contain: Iron Oxides/CI 77491/CI 77492/CI 77499, Titanium Dioxde/CI 77891] [Fragrance/Parfum contains: Limonene, Linalool, Butylphenyl Methylpropional (Lillial), Citronellol]

PRINCIPAL DISPLAY PANEL

Jafra

Tester Oil-controlling makeup Makeup SPF 15/ Moisturizing Makeup SPF 15

Muestrario de Maquiallaje Facial Matificante *FPS 15 / Maquillage Facial Humectante *FPS 15

Contains: 10 testers at .27 Fl Oz each
Contenido: 10 pzas de 8 ml c/u / 80 ml

80 ml 2.7 Fl Oz (US)

INGREDIENTS AND APPEARANCE

OIL CONTROL  TESTERS SPF 15
octinoxate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4.8 g  in 80 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.4 g  in 80 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1.6 g  in 80 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)
ZINC OXIDE (UNII: SOI2LOH54Z)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
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)
WITHANIA SOMNIFERA FLOWER (UNII: 2HZ95R7082)
MUNG BEAN (UNII: 1LIB31N73G)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
COMFREY LEAF (UNII: DG4F8T839X)
MATRICARIA RECUTITA LEAF (UNII: 6I9LN466F0)
CUCUMBER (UNII: YY7C30VXJT)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
TEA TREE OIL (UNII: VIF565UC2G)
EDETATE TRISODIUM (UNII: 420IP921MB)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
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: 68828-105-01	10 in 1 BOX	06/05/2012
1		8 mL in 1 BOTTLE; 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	06/05/2012

Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)

Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture(68828-105)