BALANCE DYNAMICS SPF 15 - octisalate, oxybenzone and octinoxate 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, TRIBEHENIN PEG-20 ESTERS, IPOMOEA DIGITATA (FINGERLEAF MORNING GLORY) EXTRACT, CENTELLA ASIATICA EXTRACT, WITHANIA SOMNIFERIA EXTRACT, BUTYLENE GLYCOL, DIMETHICONE, DIMETHICONE CROSSPOLYMER, XYLITOL, XYLITAN, XYLITYL POLYGLUCOSIDE, GLYCERYL STEARATE, BIS-DIGLYCERYL POLYACRYLADIPATE-2, IRIS FLORENTINA ROOT EXTRACT, RETINYL PALMITATE, ZINC SULFATE, ALCOHOL, PROPYLENE GLYCOL, BIOSACCHARIDE GUM-1, LAMINARIA SACCHARINA EXTRACT, GLYCERIN, BUTYROSPERMUM PARKII (SHEA BUTTER) FRUIT, DIAZOLIDINYL UREA, IODOPROPYNYL BUTYLCARBAMATE, SILANEDIOL SALICYLATE, ACRYLATES COPOLYMER, CYCLOMETHICONE,  TRIETHANOLAMINE, CHONDRUS CRISPUS (CARRAGEENAN) EXTRACT, BIOSACCHARIDE GUM-4, PANTHENOL, TOCOPHERYL  ACETATE, CARBOMER, XANTHAN GUM, FRAGRANCE/PARFUM, TRISODIUM EDTA, PENTYLENE GLYCOL, PROPAMIDOBENZOIC ACID, ZINGIBER OFFICINALE (GINGER) EXTRACT, BISABOLOL, YELLOW 6/CI 15985, RED 33/CI 17200 [FRAGRANCE/PARFUM CONTAINS: AMYL CINNAMAL, BENZYL ALCOHOL, BENZYL BENZOATE, LIMONENE, LINALOOL, BUTYLCHEMYL METHYLPROPIONAL (LILLIAL)].

BALANCING LOTION SPF 15

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

DISCONTINUE USE IF IRRITATION OCCURS.

KEEP OUT OF REACH OF CHILDREN.

JAFRA

BALANCE

DYNAMICS

BALANCING LOTION SPF 15

Balancing Dynamics_ART_BOX-FR_50mLBalancing Dynamics_ART_BOX-BK_50mLBalancing Dynamics_ART_BOX-S1_50mLBalancing Dynamics_ART_BOX-S2_50mLBalancing Dynamics_ART_LBL-FR_50mLBalancing Dynamics_ART_LBL-BK_50mLBalancing Dynamics_ART_LBL-FR_7mLBalancing Dynamics_ART_LBL-BK_7mLBalancing Dynamics_ART_INSERT_7mL


BALANCE DYNAMICS  SPF 15
octisalate oxybenzone octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-050
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (OCTISALATE) OCTISALATE4 g  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE2 g  in 100 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
TRIBEHENIN PEG-20 ESTERS 
IPOMOEA MAURITIANA TUBER 
CENTELLA ASIATICA LEAF 
WITHANIA SOMNIFERA FLOWER 
BUTYLENE GLYCOL 
DIMETHICONE 
XYLITOL 
XYLITYLGLUCOSIDE 
GLYCERYL MONOSTEARATE 
DIGLYCERIN 
IRIS GERMANICA VAR. FLORENTINA ROOT 
VITAMIN A PALMITATE 
ZINC SULFATE 
ALCOHOL 
PROPYLENE GLYCOL 
BIOSACCHARIDE GUM-1 
SACCHARINA LATISSIMA THALLUS 
SHEA BUTTER 
DIAZOLIDINYL UREA 
IODOPROPYNYL BUTYLCARBAMATE 
SILANETRIOL 
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) 
CYCLOMETHICONE 
TROLAMINE 
CHONDRUS CRISPUS 
PANTHENOL 
.ALPHA.-TOCOPHEROL ACETATE 
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED) 
XANTHAN GUM 
EDETATE TRISODIUM 
PENTYLENE GLYCOL 
BENZOIC ACID 
GINGER 
LEVOMENOL 
FD&C YELLOW NO. 6 
D&C RED NO. 33 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:68828-050-177 mL in 1 TUBENone
2NDC:68828-050-121 BOTTLE ( BOTTLE) in 1 BOXcontains a BOTTLE (68828-050-62)
2NDC:68828-050-6250 mL in 1 BOTTLEThis package is contained within the BOX (68828-050-12)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/24/201205/31/2012

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