BALANCE DYNAMICS BALANCING SPF 15- octisalate oxybenzone 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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BALANCE DYNAMICS BALANCING LOTION SPF-15

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 BALANCING  SPF 15
octisalate oxybenzone octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-150
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)  
IPOMOEA MAURITIANA TUBER (UNII: K67Y2SGX79)  
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
WITHANIA SOMNIFERA FLOWER (UNII: 2HZ95R7082)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
XYLITOL (UNII: VCQ006KQ1E)  
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
DIGLYCERIN (UNII: 3YC120743U)  
IRIS GERMANICA VAR. FLORENTINA ROOT (UNII: M30XO5X4XD)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
ZINC SULFATE (UNII: 89DS0H96TB)  
ALCOHOL (UNII: 3K9958V90M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
SACCHARINA LATISSIMA THALLUS (UNII: 68CMP2MB55)  
SHEA BUTTER (UNII: K49155WL9Y)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
SILANETRIOL (UNII: E52D0J3TS5)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
TROLAMINE (UNII: 9O3K93S3TK)  
CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
PANTHENOL (UNII: WV9CM0O67Z)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CARBOMER HOMOPOLYMER (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
GINGER (UNII: C5529G5JPQ)  
LEVOMENOL (UNII: 24WE03BX2T)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-150-177 mL in 1 TUBE
2NDC:68828-150-121 in 1 BOX
2NDC:68828-150-6250 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/24/2012
Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Jafra Manufacturing, S.A. de C.V.814732061manufacture

Revised: 5/2012
Document Id: 3a483673-b894-4efe-9021-5c10cdd637ee
Set id: 31066ffd-d8be-4390-bc91-268162945de9
Version: 1
Effective Time: 20120531
 
JAFRA COSMETICS INTERNATIONAL