Calming Dynamics Spf 15 (Octinoxate Octisalate Oxybenzone) Cream [Jafra Cosmetics International] -

CALMING DYNAMICS SPF 15 (OCTINOXATE OCTISALATE OXYBENZONE) CREAM [JAFRA COSMETICS INTERNATIONAL]
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NDC	68828-055-12, 68828-055-62
Set ID	0a02cd3f-0d10-4b74-8545-e7e11f202c0c
Category	HUMAN OTC DRUG LABEL
Packager	JAFRA COSMETICS INTERNATIONAL
Generic Name
Product Class
Product Number
Application Number	PART352

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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, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, SQUALANE, POLYSORBATE 60, TRIDECYL NEOPENTANOATE, ALUMINUM STARCH OCTENYLSUCCINATE, SACCHARIDE ISOMERATE, BUTYLENE GLYCOL, AVENA SATIVA (OAT) KERNEL EXTRACT, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LURETH-7, HEMIDESMUS INDICUS EXTRACT, PHYLLANTHUS EMBLICA EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) EXTRACT, DMDM HYDANTOIN, BIOSACCHARIDE GUM-4, CHONDRUS CRISPUS (CARRAGEENAN) EXTRACT, PANTHENOL, TOCOPHERYL ACETATE, DIMETHICONE, PUERARIA LOBATA ROOT EXTRACT, PEG-4 LAURATE, IODOPROPYNYL BUTYLCARBAMATE, TRISODIUM EDTA, PENTYLENE GLYCOL, PROPAMIDOBENZOIC ACID.
INDICATIONS & USAGE

GENTLE HYDRATING DAY 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

CALMING DYNAMICS

GENTLE HYDRATING DAY CREAM SPF 15

INGREDIENTS AND APPEARANCE

CALMING DYNAMICS SPF 15
octinoxate octisalate oxybenzone cream

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
SQUALANE (UNII: GW89575KF9)
POLYSORBATE 60 (UNII: CAL22UVI4M)
TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
OAT (UNII: Z6J799EAJK)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
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)
PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)
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)

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

Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)

Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)

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

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