OIL CONTROLLING MAKEUP SPF 15

Dosage form: lotion
Ingredients: OCTINOXATE 6g in 100mL, OCTISALATE 3g in 100mL, OXYBENZONE 2g in 100mL
Labeler: JAFRA COSMETICS INTERNATIONAL
NDC Code: 68828-046

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

OIL CONTROLLING MAKEUP SPF-15

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

PURPOSE: SUNSCREEN

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]

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

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

TO USE: SMOOTH ON WITH FINGERS OR SPONGE.

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

DISCONTINUE USE IF SIGNS OF IRRITATION OCCUR.

KEEP OUT OF REACH OF CHILDREN.

CLINICALLY, ALLERGY AND IRRITANCY TESTED.

JAFRA

OIL CONTROLLING MAKEUP SPF 15

30 ML / 1 FL OZ

OIL CONTROLLING MAKEUP  SPF 15
octinoxate octisalate oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-046
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE6 g  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE3 g  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
BUTYLENE GLYCOL 
ISOPROPYL PALMITATE 
ISOPROPYL ISOSTEARATE 
POTASSIUM CETYL PHOSPHATE 
HYDROGENATED PALM GLYCERIDES 
GLYCERYL MONOSTEARATE 
DI-PPG-3 MYRISTYL ETHER ADIPATE 
SILICON DIOXIDE 
STEARIC ACID 
ZINC OXIDE 
POLYSORBATE 20 
LECITHIN, SOYBEAN 
POLYSILICONE-15 
LAURETH-12 
CYCLOMETHICONE 5 
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) 
DMDM HYDANTOIN 
TRIHYDROXYSTEARIN 
MAGNESIUM ALUMINUM SILICATE 
XANTHAN GUM 
PANTHENOL 
IPOMOEA MAURITIANA TUBER 
WITHANIA SOMNIFERA FLOWER 
MUNG BEAN 
ALPHA-TOCOPHEROL ACETATE 
HAMAMELIS VIRGINIANA BARK 
COMFREY LEAF 
CHAMOMILE 
CUCUMBER 
ALOE VERA LEAF 
ALTHAEA OFFICINALIS ROOT 
TEA TREE OIL 
EDETATE TRISODIUM 
PEG-4 LAURATE 
IODOPROPYNYL BUTYLCARBAMATE 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
TITANIUM DIOXIDE 
Packaging
#Item CodePackage Description
1NDC:68828-046-671 BOTTLE (BOTTLE) in 1 BOX
1NDC:68828-046-1130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/19/2012
Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)

Revised: 04/2012
 
JAFRA COSMETICS INTERNATIONAL

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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