GOLD DYNAMICS TRAVEL KIT JAFRA- avobenzone, oxtinoxate, octisalate, oxybenzone kit

Gold Dynamics Travel Kit by

Drug Labeling and Warnings

Gold Dynamics Travel Kit by is a Otc medication manufactured, distributed, or labeled by Jafra Cosmetics International Inc, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

Avobenzone 2.5 % Sunscreen

Octinoxate 7.5 % Sunscreen

Octisalate 4.0 % Sunscreen

Oxybenzone 2.0% Sunscreen

Uses

Helps prevent sunnburn

If used as directed, with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if rash occurs.

Warnings

For external use only

Do not use on damaged or broken skin

When using this project keep out of eyes. Rinse with water to remove.

Directions

apply liberally 15 minutes before sun exposure

use a water resistant sunscreen if swimming or sweating

reapply at least every 2 hours

children under 6 months: Ask a doctor

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk. regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures , including:

limit time in the sun, especially from 10 a.m. - 2 p.m.

wear long-sleeve shirts, pants, hats and sunglasses

Inactive ingredients: Water/aqua, Cetearyl Alcohol, Cetearyl Alcohol, Ceteareth-20, Glycerin, Stearyl Stearate, Myristyl Myristate, Sodium PCA, Pentylene Glycol, Garcinia Indica Seed Butter, Cyclomethicone, Dimethiconol, Bis-Diglyceryl Polyacrylamide-2, Cetyl Alcohol, Butyrospermum Parkii (Shea Butter) Fruit, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Castanea Sativa (Chestnut) Seed Extract, Carica Papaya Extract, Glycyrrhiza Glabra (Licorice) Extract, Saccharomyces/Gold Ferment Lysate Filtrate, Fragrance/Parfum, Acrylates/C10-30 Alkyl Benzoate, Tribehenin, Triethanolamine, Panthenol, Citronellol, Biosaccharide-4, Chondrus Crispus (carrageenan) Extract, Glycine Soja (soybean) Isoflavone Aglyone, Lecithin, Polysorbate 80, Alcohol, Tocopheryl Acetate, Trisodium EDTA, PEG-4 Laurate, Iodopropyl Butylcarbamate, Smithsonite Extract, Limonene, Linalool 

PRINCIPAL DISPLAY PANEL

Jafra Gold Dynamics Dynamic Travel Kit

Skin Boosting Moisturizer Broad Spectrum SPF 15

7.5 ml .25 Fl Oz

INGREDIENTS AND APPEARANCE

GOLD DYNAMICS TRAVEL KIT  JAFRA
avobenzone, oxtinoxate, octisalate, oxybenzone kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-205

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-205-01	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	12/14/2014

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	7.5 mL
Part 2	1 TUBE	15 mL
Part 3	1 BOTTLE	7.5 mL

Part 1 of 3

SKIN BOOSTING MOISTURIZER BROAD SPECTRUM SPF 15  JAFRA
avobenzone, octinoxate, octisalate, oxybenzone cream

Product Information
Item Code (Source)	NDC: 68828-206
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.0 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2.0 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)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
SHEA BUTTER (UNII: K49155WL9Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
SPANISH CHESTNUT (UNII: 2MT5XMR2YW)
PAPAYA (UNII: KU94FIY6JB)
LICORICE (UNII: 61ZBX54883)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CERAMIDE 2 (UNII: C04977SRJ5)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
TROLAMINE (UNII: 9O3K93S3TK)
PANTHENOL (UNII: WV9CM0O67Z)
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE TRISODIUM (UNII: 420IP921MB)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
LINALOOL, (+)- (UNII: F4VNO44C09)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-206-01	7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
2	NDC: 68828-206-02	2 mL in 1 POUCH; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/14/2014

Part 2 of 3

REVITALIZING TONING CLEANSER  JAFRA
face and neck (excluding shaving preparations)

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
INGR	COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	BENZOIC ACID (UNII: 8SKN0B0MIM)
INGR	DEHYDROACETIC ACID (UNII: 2KAG279R6R)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	ALLANTOIN (UNII: 344S277G0Z)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
INGR	SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
INGR	STANNIC OXIDE (UNII: KM7N50LOS6)
INGR	TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
INGR	.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	LINALOOL, (+)- (UNII: F4VNO44C09)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		15 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
2		2 mL in 1 POUCH; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		12/14/2014

Part 3 of 3

FIRM AND CORRECT NIGHT MOISTURIZER  JAFRA
face and neck (excluding shaving preparations)

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
INGR	POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
INGR	ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
INGR	ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	STEARYL STEARATE (UNII: 5WX2EGD0DK)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)
INGR	YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
INGR	UREA (UNII: 8W8T17847W)
INGR	DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	HEXYLENE GLYCOL (UNII: KEH0A3F75J)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
INGR	TROLAMINE (UNII: 9O3K93S3TK)
INGR	CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
INGR	BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	SWEET POTATO (UNII: M9WGG9Z9GK)
INGR	MUNG BEAN (UNII: 1LIB31N73G)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	ALLANTOIN (UNII: 344S277G0Z)
INGR	EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
INGR	EDETATE TRISODIUM (UNII: 420IP921MB)
INGR	POLYETHYLENE TEREPHTHALATE (INTRINSIC VISCOSITY 0.40-0.70) (UNII: Y78AJD3DED)
INGR	ALUMINUM (UNII: CPD4NFA903)
INGR	FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
INGR	MICA (UNII: V8A1AW0880)
INGR	TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
INGR	STANNIC OXIDE (UNII: KM7N50LOS6)
INGR	FERRIC OXIDE RED (UNII: 1K09F3G675)
INGR	FERROSOFERRIC OXIDE (UNII: XM0M87F357)
INGR	FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
INGR	CINNAMYL ALCOHOL (UNII: SS8YOP444F)
INGR	BENZYL SALICYLATE (UNII: WAO5MNK9TU)
INGR	CINNAMALDEHYDE (UNII: SR60A3XG0F)
INGR	HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)
INGR	.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)
INGR	.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
INGR	LINALOOL, (+)- (UNII: F4VNO44C09)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		7.5 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
2		2 mL in 1 POUCH; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		12/14/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/14/2014

Labeler - Jafra Cosmetics International Inc (041676479)

Registrant - Jafra Cosmetics International Inc (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture(68828-205, 68828-206)