MOISTURIZING MAKEUP SPF 15- octinoxate octisalate oxybenzone lotion

MOISTURIZING MAKEUP by

Drug Labeling and Warnings

MOISTURIZING 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, SILICA, DI-PPG-3 MYRISTYL ETHER ADIPATE, GLYCERYL STEARATE, STEARIC ACID, SACCHARIDE ISOMERATE, POLYSORBATE 20, LECITHIN, BUTYROSPERMUM PARKII (SHEA BUTTER) FRUIT, POLYSILICONE-11, LAURETH-12, CYCLOPENTASILOXANE, ACRYLATES/DIMETHICONE COPOLYMER, METHYLSILANOL MANNURONATE, DMDM HYDANTOIN, TRIHYDROXYSTEARIN, MAGNESIUM ALUMINUM SILICATE, XANTHAN GUM, IPOMOEA DIGITATA (FINGERLEAF MORNING GLORY) EXTRACT, WITHANIA SOMNIFERIA (WINTER CHERRY) EXTRACT, VIGNA RADIATA (MUNG BEAN) EXTRACT, PANTHENOL, TOCOPHERYL ACETATE, FRAGRANCE/PARFUM, TETRASODIUM EDTA, PEG-4 LAURATE, IODOPROPYNYL BUTYLCARBAMATE, BORAGO OFFICINALIS EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, ALGAE EXTRACT, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL [MAY CONTAIN, +/-: IRON OXIDES/CI 77491/CI 77492/CI 77499, TITANIUM DIOXIDE/CI 77891]  [FRAGRANCE/PARFUM CONTAINS: LIMONENE, LINALOOL, BUTYLPHENYL METHYLPROPIONAL (LILIAL), CITRONELLOL]

INDICATIONS & USAGE

MOISTURIZING MAKEUP WITH SPF 15

INSTRUCTIONS FOR USE

TO USE: SMOOTH ON WITH FINGERS OR SPONGE.

WARNINGS

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

MOISTURIZING MAKEUP SPF 15

30 ML / 1 FL OZ

INGREDIENTS AND APPEARANCE

MOISTURIZING MAKEUP  SPF 15
octinoxate octisalate oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-048
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)
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)
BORAGE (UNII: PB618V0K2W)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
JOJOBA OIL (UNII: 724GKU717M)
EDETATE SODIUM (UNII: MP1J8420LU)
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)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
SHEA BUTTER (UNII: K49155WL9Y)
METHYLSILANOL ACETYLMETHIONATE (UNII: FKT0KP5RFC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-048-11	1 in 1 BOX
1	NDC: 68828-048-67	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	05/01/2012

Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)