HARMONY DYNAMICS FACIAL BOOSTING SPF 15- octinoxate octisalate oxybenzone cream

HARMONY DYNAMICS FACIAL BOOSTING by

Drug Labeling and Warnings

HARMONY DYNAMICS FACIAL BOOSTING 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

INGREDIENTS: WATER/AQUA, CETEARYL ALCOHOL, CETEARETH-20, GLYCERIN, STEARYL STEARATE, MYRISTYL MYRISTATE, GARCINIA INDICA SEED BUTTER, SODIUM PCA, CYCLOMETHICONE, DIMETHICONOL, PENTYLENE GLYCOL, BIS-DIGLYCERYL POLYACRYLADIPATE-2, BUTYROSPERMUM PARKII (SHEA BUTTER) FRUIT, CASTANEA SATIVA (CHESTNUT) EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) EXTRACT, MORINGA OLIEFERA EXTRACT, VETIVERA ZINZANOIDS (KHUS ROOT) EXTRACT, WITHANIA SOMNIFERIA (WINTER CHERRY) EXTRACT, MENTHA PIPERTITA (PEPPERMINT) EXTRACT, CERAMIDE 2, PEG 10 BRASSICA CAMESTRIS STEROL, PALMITOYL OLIGOPEPTIDE, C12-15 ALKYL BENZOATE, TRIBEHENIN, CETYL ALCOHOL, PHENOXYETHANOL, METHYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, BUTYLPARABEN, TOCOPHEROL, GLYCEINE SOJA (SOYBEAN) ISOFLAVONE AGLYONE, LECITHIN, POLYSORBATE 80, ALCOHOL, FRAGRANCE/PARFUM, TRIETHANOLAMINE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, DMDM HYDANTOIN, PANTHENOL, BIOSACCHARIDE GUM-4, CHONDRUS CRISPUS (CARRAGEENAN) EXTRACT, PEG-4 LAURATE, IODOPROPYL BUTYLCARBAMATE, TRISODIUM EDTA.

DESCRIPTION

A LUXURIOUS RICH CREAM FOR COMPLEXIONS AFFECTED BY HORMONAL IMBALANCES AND AGING WHICH CAN MAKE THE SKIN DRY AND LACK VITALITY.

INDICATIONS & USAGE

THIS UNIQUE FORMULA HELPS SOOTHE AND SMOOTH THE SKIN WHILE FIGHTING AGAINST SIGNS OF AGING AND CONTAINS A PRO-ENDORPHIN COMPLEX THAT HELPS PROVIDE A PLEASURABLE SENSATION TO THE SKIN, CREATING A VISIBLE APPEARANCE OF REFRESHED, YOUNGER AND MORE RADIANT LOOKING SKIN.

INSTRUCTIONS FOR USE

TO USE: SMOOTH OVER FACE AND THROAT DAY AND NIGHT AFTER CLEANSING.

WARNINGS

CAUTION: FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES.

STOP USE

DISCONTINUE USE IF SIGNS OF IRRITATION APPEAR.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

OTHER SAFETY INFORMATION

CLINICALLY, ALLERGY, IRRITANCY AND DERMATOLOGIST TESTED.

PRINCIPAL DISPLAY PANEL

JAFRA

HARMONY DYNAMICS

FACIAL BOOSTING CREAM SPF 15

WITH / CON INTELLISHIELD

        

  

INGREDIENTS AND APPEARANCE

HARMONY DYNAMICS FACIAL BOOSTING  SPF 15
octinoxate octisalate oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-163
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
GLYCERIN (UNII: PDC6A3C0OX)
STEARYL STEARATE (UNII: 5WX2EGD0DK)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIMETHICONOL (250000 MW) (UNII: RKI3S914RT)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DIGLYCERIN (UNII: 3YC120743U)
SHEA BUTTER (UNII: K49155WL9Y)
SPANISH CHESTNUT (UNII: 2MT5XMR2YW)
LICORICE (UNII: 61ZBX54883)
MORINGA OLEIFERA LEAF (UNII: 4WET1AWO9B)
VETIVERIA ZIZANIOIDES ROOT (UNII: 37TB8LUP9Z)
WITHANIA SOMNIFERA LEAF (UNII: J337CNM3CW)
PEPPERMINT (UNII: V95R5KMY2B)
CERAMIDE 2 (UNII: C04977SRJ5)
CAMPESTEROL (UNII: 5L5O665639)
PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
CETYL ALCOHOL (UNII: 936JST6JCN)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
TOCOPHEROL (UNII: R0ZB2556P8)
SOYBEAN (UNII: L7HT8F1ZOD)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)
DMDM HYDANTOIN (UNII: BYR0546TOW)
PANTHENOL (UNII: WV9CM0O67Z)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
EDETATE TRISODIUM (UNII: 420IP921MB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-163-12	1 in 1 BOX
1	NDC: 68828-163-62	50 mL in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/19/2012

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