CONTROL DYNAMICS SPF 15 - octinoxate, octisalate and oxybenzone lotion 
JAFRA COSMETICS INTERNATIONAL

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.

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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 SPF-15 ART_30mL-Box-FR   Control Dynamics SPF-15 ART_30mL-Box-BK   Control Dynamics SPF-15 ART_30mL-Box-S1


Control Dynamics SPF-15 ART_30mL-BTL-FR   Control Dynamics SPF-15 ART_30mL-BTL-BK


Control Dynamics SPF-15 ART_7mL-Box-FR

Control Dynamics SPF-15 ART_7mL-Tube-FR   Control Dynamics SPF-15 ART_7mL-Tube-BK


CONTROL DYNAMICS  SPF 15
octinoxate octisalate oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-058
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 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:68828-058-121 BOTTLE ( BOTTLE) in 1 BOXcontains a BOTTLE (68828-058-62)
1NDC:68828-058-6250 mL in 1 BOTTLEThis package is contained within the BOX (68828-058-12)

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