HYDRATION DYNAMICS SPF 15 - octinoxate, octisalate and oxybenzone cream 
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/ETHYLHEXYL METHOXYCINNAMATE, OCTISALATE/ETHYLHEXYL SALICYLATE, OXYBENZONE/BENZOPHENONE-3

PURPOSE: SUNSCREEN

OTHER INGREDIENTS: WATER/AQUA, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIMETHICONE, PEG-8 BEESWAX/CERA ALBA, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7, CETYL ALCOHOL, CETETH-20, STEARETH-20, GLYCERIN, METHYLSILANOL MANNURONATE, HEMIDESMUS INDICUS EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) EXTRACT, WITHANIA SOMNIFERIA EXTRACT, BUTYLENE GLYCOL, SACCHARIDE ISOMERATE, SODIUM PCA, SODIUM HYALURONATE, TREHALOSE, POLYQUATERNIUM-51, UREA, GLYCERYL STEARATE, HYDROGENATED AVOCADO OIL, DIMETHICONE, DIMETHICONE CROSSPOLYMER, BUTYROSPERMUM PARKII (SHEA BUTTER) FRUIT, PROPYLENE GLYCOL, CODIUM TOMENTOSUM EXTRACT, DIAZOLIDINYL UREA, IODOPROPYNYL BUTYLCARBAMATE, FRAGRANCE/PARFUM, ACRYLATES COPOLYMER, CHONDRUS CRISPUS (CARRAGEENAN) EXTRACT, BIOSACCHARIDE GUM-4, PANTHENOL, TOCOPHERYL ACETATE, TRISODIUM EDTA, GLYCINE SOYA (SOYBEAN) SEED EXTRACT, CERAMIDE 3, GLYCERYL POLYMETHACRYLATE, PALMITOYL OLIGOPEPTIDE, PENTYLENE GLYCOL, PROPAMIDOBENZOIC ACID, ZINGIBER OFFICINALE (GINGER) EXTRACT, BISABOLOL, RED 33/CI 17200, BLUE 1/CI 42090 [FRAGRANCE/PARFUM CONTAINS: CINNAMYL ALCOHOL, HYDROXYCITRONELLAL, BENZYL SALICYLATE, HYDROXYISOHEXYL 3-CYCLOHEXANE CARBOXALDEHYDE (LYRAL), BENZYL BENZOATE, CITRONELLOL, ALPHA-ISOMETHYL IONONE]

MOISTURE REPLENISHING CREAM 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

HYDRATION DYNAMICS

MOISTURE REPLENISHING CREAM SPF 15


Hydration Dynamics_SPF-15_50mL_Box-FR   Hydration Dynamics_SPF-15_50mL_Box_BK


Hydration Dynamics_SPF-15_50mL_LBL_FR   Hydration Dynamics_SPF-15_50mL_LBL_BK


Hydration Dynamics SPF-15 ART_7mL_Box-FR

Hydration Dynamics SPF-15 ART_7mL_Tube-FR   Hydration Dynamics SPF-15 ART_7mL_Tube-BK


HYDRATION DYNAMICS  SPF 15
octinoxate octisalate oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-056
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE6.5 g  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE4 g  in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
MEDIUM-CHAIN TRIGLYCERIDES 
DIMETHICONE 
POLYETHYLENE GLYCOL 400 
POLYACRYLAMIDE (10000 MW) 
C13-14 ISOPARAFFIN 
SACCHARIDE ISOMERATE 
LAURETH-7 
CETYL ALCOHOL 
CETETH-20 
STEARETH-20 
HEMIDESMUS INDICUS ROOT 
BIOSACCHARIDE GUM-1 
PHYLLANTHUS EMBLICA FRUIT 
GLYCYRRHIZA GLABRA 
IODOPROPYNYL BUTYLCARBAMATE 
DMDM HYDANTOIN 
SHEA BUTTER 
CHONDRUS CRISPUS 
PANTHENOL 
.ALPHA.-TOCOPHEROL ACETATE 
PENTYLENE GLYCOL 
HYDROXYPHENYL PROPAMIDOBENZOIC ACID 
PEG-4 LAURATE 
GLYCERIN 
METHYLSILANOL ASCORBATE 
WITHANIA SOMNIFERA FLOWER 
BUTYLENE GLYCOL 
SODIUM PYRROLIDONE CARBOXYLATE 
HYALURONATE SODIUM 
TREHALOSE 
POLIDRONIUM CHLORIDE 
UREA 
GLYCERYL MONOSTEARATE 
AVOCADO OIL 
PROPYLENE GLYCOL 
CODIUM TOMENTOSUM 
DIAZOLIDINYL UREA 
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) 
EDETATE TRISODIUM 
SOYBEAN SEED OIL 
CERAMIDE 3 
GLYCERYL 1-ADIPATE 
PALMITOYL OLIGOPEPTIDE 
GINGER 
LEVOMENOL 
D&C RED NO. 33 
FD&C BLUE NO. 1 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:68828-056-121 JAR ( JAR) in 1 BOXcontains a JAR (68828-056-62)
1NDC:68828-056-6250 mL in 1 JARThis package is contained within the BOX (68828-056-12)
2NDC:68828-056-271 TUBE ( TUBE) in 1 BOXcontains a TUBE (68828-056-17)
2NDC:68828-056-177 mL in 1 TUBEThis package is contained within the BOX (68828-056-27)

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