OIL CONTROLLING MAKEUP SPF 15- octinoxate octisalate oxybenzone lotion

OIL CONTROLLING MAKEUP by

Drug Labeling and Warnings

OIL CONTROLLING MAKEUP by is a Otc medication manufactured, distributed, or labeled by JAFRA COSMETICS INTERNATIONAL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

SUNSCREEN ACTIVE INGREDIENT (SPF 15):
OCTINOXATE/ETHYLHEXYL METHOXYCINNAMATE, OCTISALATE/ETHYLHEXYL SALICYLATE, OXYBENZONE/BENZOPHENONE-3

PURPOSE

PURPOSE: SUNSCREEN

INACTIVE INGREDIENT

OTHER INGREDIENTS: WATER/AQUA, BUTYLENE GLYCOL, ISOPROPYL PALMITATE, ISOPROPYL ISOSTEARATE, POTASSIUM CETHYL PHOSPHATE, HYDROGENATED PALM GLYCERIDES, 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 SOMNIFERIA (WINTER CHERRY) EXTRACT, VIGNA RADIATA (MUNG BEAN) EXTRACT, TOCOPHERYL ACETATE, HAMAMELIS VIRGINIA (WITCH HAZEL) EXTRACT, SYMPHYTUM OFFICINALIS 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, IODOPROPYNYL BUTYLCARBAMATE [MAY CONTAIN, +/-: IRON OXIDES/CI 77491/CI 77492/CI 77499, TITANIUM DIOXIDE/CI 77891]  [FRAGRANCE/PARFUM CONTAINS: LIMONENE, LINALOOL, BUTYLPHENYL METHYLPROPIONAL (LILIAL), CITRONELLOL]

DESCRIPTION

AN OIL FREE, LIQUID MAKEUP THAT CONTROLS EXCESS OIL AND PROVIDES FLAWLESS COVERAGE WITHOUT SHINE.

INDICATIONS & USAGE

SPF 15 PROTECTS AGAINST DAMAGING ULTRAVIOLET RAYS. MATTE FINISH. SHEER TO MEDIUM COVERAGE.

INSTRUCTIONS FOR USE

TO USE: SMOOTH ON WITH FINGERS OR SPONGE.

WARNINGS

CAUTION: FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES.

STOP USE

DISCONTINUE USE IF SIGNS OF IRRITATION OCCUR.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

OTHER SAFETY INFORMATION

CLINICALLY, ALLERGY AND IRRITANCY TESTED.

PRINCIPAL DISPLAY PANEL

JAFRA

OIL CONTROLLING MAKEUP SPF 15

30 ML / 1 FL OZ

INGREDIENTS AND APPEARANCE

OIL CONTROLLING MAKEUP  SPF 15
octinoxate octisalate oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-046
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)
POLYSILICONE-15 (UNII: F8DRP5BB29)
LAURETH-12 (UNII: OAH19558U1)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)
DMDM HYDANTOIN (UNII: BYR0546TOW)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
XANTHAN GUM (UNII: TTV12P4NEE)
PANTHENOL (UNII: WV9CM0O67Z)
IPOMOEA MAURITIANA TUBER (UNII: K67Y2SGX79)
WITHANIA SOMNIFERA FLOWER (UNII: 2HZ95R7082)
MUNG BEAN (UNII: 1LIB31N73G)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY)
COMFREY LEAF (UNII: DG4F8T839X)
CHAMOMILE (UNII: FGL3685T2X)
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)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-046-67	1 in 1 BOX
1	NDC: 68828-046-11	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/19/2012

Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)