CALMING DYNAMICS SPF 15- octinoxate octisalate oxybenzone cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)

Available from:

JAFRA COSMETICS INTERNATIONAL

INN (International Name):

OCTINOXATE

Composition:

OCTINOXATE 7 g in 100 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

PURPOSE: SUNSCREEN GENTLE HYDRATING DAY CREAM SPF 15

Authorization status:

OTC monograph not final

Summary of Product characteristics

CALMING DYNAMICS 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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CALMING DYNAMICS
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
octinoxate octisalate oxybenzone cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 8 8 28 -0 55
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)
OCTINOXATE
7 g in 10 0 mL
O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)
OCTISALATE
4 g in 10 0 mL
O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y)
OXYBENZONE
2 g in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
HYDRO XYETHYL ACRYLATE/SO DIUM ACRYLO YLDIMETHYL TAURATE CO PO LYMER