HYDRATION DYNAMICS MOISTURE REPLENISHMENT SPF 15- octinoxate octisalate 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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HYDRATION DYNAMICS MOISTURE REPLENISHMENT CREAM SPF-15

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 MOISTURE REPLENISHMENT  SPF 15
octinoxate octisalate oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-156
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
LAURETH-7 (UNII: Z95S6G8201)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETETH-20 (UNII: I835H2IHHX)  
STEARETH-20 (UNII: L0Q8IK9E08)  
HEMIDESMUS INDICUS ROOT (UNII: Y5CFT48S90)  
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
SHEA BUTTER (UNII: K49155WL9Y)  
CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
PANTHENOL (UNII: WV9CM0O67Z)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)  
PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLSILANOL ASCORBATE (UNII: 46Z5D1I0IS)  
WITHANIA SOMNIFERA FLOWER (UNII: 2HZ95R7082)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
TREHALOSE (UNII: B8WCK70T7I)  
POLIDRONIUM CHLORIDE (UNII: 6716Z5YR3G)  
UREA (UNII: 8W8T17847W)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CODIUM TOMENTOSUM (UNII: B8B45BRU87)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
SOYBEAN SEED OIL (UNII: P6C7NVO1UF)  
CERAMIDE 3 (UNII: 4370DF050B)  
GLYCERYL 1-ADIPATE (UNII: 6UXO8KCR3J)  
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
GINGER (UNII: C5529G5JPQ)  
LEVOMENOL (UNII: 24WE03BX2T)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-156-121 in 1 BOX
1NDC:68828-156-6250 mL in 1 JAR
2NDC:68828-156-271 in 1 BOX
2NDC:68828-156-177 mL in 1 TUBE
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: b3ef9b24-e8b0-4787-a9a4-21aee5a47a48
Set id: ef04ec43-7100-43f0-90f6-7c9ba65e66e8
Version: 1
Effective Time: 20120531
 
JAFRA COSMETICS INTERNATIONAL