OTC Medication Information: CALM DYNAMICS GENTLE HYDRATING DAY SPF 15

CALM DYNAMICS GENTLE HYDRATING DAY 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.

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

PURPOSE: SUNSCREEN

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.

GENTLE HYDRATING DAY 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

CALMING DYNAMICS

GENTLE HYDRATING DAY CREAM SPF 15

Calming Dynamics SPF-15_ART_Box-FR_50mL
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Calming Dynamics SPF-15_ART_Box-BK_50mL
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Calming Dynamics SPF-15_ART_LBL-FR_50mL
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Calming Dynamics SPF-15_ART_LBL-BK_50mL
(click image for full-size original)

CALM DYNAMICS GENTLE HYDRATING DAY SPF 15
octinoxate octisalate oxybenzone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-155
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 7 g in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE 4 g in 100 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE 2 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)
SQUALANE
POLYSORBATE 60
TRIDECYL NEOPENTANOATE
ALUMINUM STARCH OCTENYLSUCCINATE
SACCHARIDE ISOMERATE
OAT
POLYACRYLAMIDE (10000 MW)
C13-14 ISOPARAFFIN
LAURETH-7
HEMIDESMUS INDICUS ROOT
BIOSACCHARIDE GUM-1
PHYLLANTHUS EMBLICA FRUIT
GLYCYRRHIZA GLABRA
IODOPROPYNYL BUTYLCARBAMATE
DMDM HYDANTOIN
PUERARIA MONTANA VAR. LOBATA ROOT
CHONDRUS CRISPUS
PANTHENOL
.ALPHA.-TOCOPHEROL ACETATE
PENTYLENE GLYCOL
HYDROXYPHENYL PROPAMIDOBENZOIC ACID
PEG-4 LAURATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68828-155-12 1 JAR (JAR) in 1 BOX contains a JAR (68828-155-62)
1 NDC:68828-155-62 50 mL in 1 JAR This package is contained within the BOX (68828-155-12)
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 Operations
Jafra Manufacturing, S.A. de C.V. 814732061 manufacture

Revised: 05/2012 JAFRA COSMETICS INTERNATIONAL

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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