CONTROL DYNAMICS MATTIFYING SPF 15

Dosage form: lotion
Ingredients: OCTINOXATE 7g in 100mL, OCTISALATE 4g in 100mL, OXYBENZONE 2g in 100mL
Labeler: JAFRA COSMETICS INTERNATIONAL
NDC Code: 68828-158

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.

CONTROL DYNAMICS MATTIFYING LOTION SPF 15

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

PURPOSE: SUNSCREEN

OTHER INGREDIENTS: WATER/AQUA, AZADIRACHTA INDICA EXTRACT, TAGETUS ERECTA (AFRICN MARIGOLD) EXTRACT, IPOMOEA DIGITATA (FINGERLEAF MORNING GLORY) EXTRACT, BUTYLENE GLYCOL, ALUMINUM STARCH OCTENYLSUCCINATE, SODIUM POLYACRYLATE, HYDROGENATED POLYDECENE, TRIDECETH-6, LYSINE CARBOXYMETHYL CYSTEINATE, LYSINE THIAZOLIDINE CARBOXYLATE, DECAMETHYLCYCLOPENTASILOXANE, SACCHARIDE ISOMERATE, MALIC ACID, HYDROLYZED PRUNUS AMGDALUS DULCIS (SWEET ALMOND) PROTEIN, PANTHENOL, PROPYLENE GLYCOL, DIAZOLIDINYL UREA, IODOPROPYNYL BUTYLCARBAMATE, BIOSACCHARIDE GUM-4, BUTYL AVOCADATE, CHONDRUS CRISPUS, (CARRAGEENAN) EXTRACT, TOCOPHERYL ACETATE, FRAGRANCE/PARFUM, TRISODIUM EDTA, PENTYLENE GLYCOL, PROPAMIDOBENZOIC ACID, ZINGIBER OFFICINALE (GINGER) EXTRACT, BISABOLOL, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, POLYSORBATE 20, ETHOXYLATED CASTOR OIL, BLUE 1/CI 42090, YELLOW 5/CI 19140 [FRAGRANCE/PARFUM CONTAINS: BUTYLPHENYL METHYLPROPIONAL (LILLIAL), COUMARIN,  LIMONENE, LINALOOL, HEXYL CINNAMAL]

MATTIFYING LOTION SPF 15

TO USE: IN THE MORNING AFTER CLEANSING, SMOOTH OVER FACE AND THROAT.

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

DISCONTINUE USE IF IRRITATION OCCUR.

KEEP OUT OF REACH OF CHILDREN.

JAFRA

CONTROL DYNAMICS


MATTIFYING LOTION SPF 15




  


  

CONTROL DYNAMICS MATTIFYING  SPF 15
octinoxate octisalate oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-158
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE7 g  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE4 g  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
AZADIRACHTA INDICA BARK 
TAGETES ERECTA FLOWER 
IPOMOEA MAURITIANA TUBER 
BUTYLENE GLYCOL 
ALUMINUM STARCH OCTENYLSUCCINATE 
SODIUM POLYACRYLATE (8000 MW) 
HYDROGENATED POLYDECENE (550 MW) 
TRIDECETH-6 
CYSTEINE, DL- 
LYSINE HYDROCHLORIDE 
CYCLOMETHICONE 5 
SACCHARIDE ISOMERATE 
MALIC ACID 
ALMOND 
PANTHENOL 
PROPYLENE GLYCOL 
DIAZOLIDINYL UREA 
IODOPROPYNYL BUTYLCARBAMATE 
BIOSACCHARIDE GUM-1 
PERSEA AMERICANA LEAF 
CHONDRUS CRISPUS 
.ALPHA.-TOCOPHEROL ACETATE 
EDETATE TRISODIUM 
PENTYLENE GLYCOL 
HYDROXYPHENYL PROPAMIDOBENZOIC ACID 
GINGER 
LEVOMENOL 
TEA TREE OIL 
POLYSORBATE 20 
POLYOXYL 60 CASTOR OIL 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage Description
1NDC:68828-158-121 BOTTLE (BOTTLE) in 1 BOX
1NDC:68828-158-6250 mL in 1 BOTTLE
2NDC:68828-158-271 TUBE (TUBE) in 1 BOX
2NDC:68828-158-177 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/14/2012
Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)
Establishment
NameAddressID/FEIOperations
Jafra Manufacturing, S.A. de C.V.814732061manufacture

Revised: 05/2012
 
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.

Hide
(web1)