HYDRATION DYNAMICS MOISTURE REPLENISHMENT SPF 15- octinoxate octisalate oxybenzone cream

HYDRATION DYNAMICS MOISTURE REPLENISHMENT by

Drug Labeling and Warnings

HYDRATION DYNAMICS MOISTURE REPLENISHMENT by is a Otc medication manufactured, distributed, or labeled by JAFRA COSMETICS INTERNATIONAL, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

SUNSCREEN ACTIVE INGREDIENT (SPF 15):
OCTINOXATE/ETHYLHEXYL METHOXYCINNAMATE, OCTISALATE/ETHYLHEXYL SALICYLATE, OXYBENZONE/BENZOPHENONE-3

PURPOSE

PURPOSE: SUNSCREEN

INACTIVE INGREDIENT

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]

INDICATIONS & USAGE

MOISTURE REPLENISHING CREAM SPF 15

DOSAGE & ADMINISTRATION

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

WARNINGS

DISCONTINUE USE IF IRRITATION OCCURS.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL

JAFRA

HYDRATION DYNAMICS

MOISTURE REPLENISHING CREAM SPF 15

  

  

  

INGREDIENTS AND APPEARANCE

HYDRATION DYNAMICS MOISTURE REPLENISHMENT  SPF 15
octinoxate octisalate oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-156
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	6.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-156-12	1 in 1 BOX
1	NDC: 68828-156-62	50 mL in 1 JAR
2	NDC: 68828-156-27	1 in 1 BOX
2	NDC: 68828-156-17	7 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/24/2012

Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)

Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture