TIME DYNAMICS TRAVEL KIT JAFRA- octinoxate, zinc oxide kit

Time Dynamics Travel Kit by

Drug Labeling and Warnings

Time 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

Octinoxate 7.0 % Sunscreen

Zinc Oxide 3%    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, Tridecyl Neopentanoate, Polyglyceryl-3 Methylglucose Distearate, Glyceryl Stearate, Dimethicone, Glycerin, Tricitum Vulgare  (Wheat) Germ, Protein, Avena Sativa (Oat) Kernel Protein, Saccharide Isomerate, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Panthenol, DMDM Hydantoin, Diazolidinyl Urea, Biosaccharide Gum-4, Lecithin, Tocopheryl Acetate, Caprylic/Capric Triglyceride, Ubiquinone, Diisopropyl Adipate, Alcohol, Chondrus Chrispus (Carrageenan) Extract, Chlorella Vulgaris Extract, Phytosterol Isostearate, Allantoin, Retinyl Palmitate, Ascorbyl Methyl Pectinate, Trisodiuim EDTA, PEG-4 Laurate, Iodopropyl Butylcarbamate, Propylene Glycol, Camellia Sinensis Leaf Extract Glycine Soja (Soybean) Seed extract, Ceramide 3, Smithsonite Extract

PRINCIPAL DISPLAY PANEL

Time Protector Moisturizer Broad Spectrum SPF 15

7.5 ml  .25 FL OZ

INGREDIENTS AND APPEARANCE

TIME DYNAMICS TRAVEL KIT  JAFRA
octinoxate, zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-209

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-209-01	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	11/30/2014

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	7.4 mL
Part 2	0 TUBE	7.4 mL
Part 3	1 BOTTLE	7.4 mL

Part 1 of 3

TIME PROTECTOR MOISTURIZER BROAD SPECTRUM SPF 15  JAFRA
octinoxate, zinc oxide cream

Product Information
Item Code (Source)	NDC: 68828-210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
WHEAT GERM (UNII: YR3G369F5A)
OAT (UNII: Z6J799EAJK)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
PANTHENOL (UNII: WV9CM0O67Z)
DMDM HYDANTOIN (UNII: BYR0546TOW)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
UBIDECARENONE (UNII: EJ27X76M46)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
ALCOHOL (UNII: 3K9958V90M)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
ALLANTOIN (UNII: 344S277G0Z)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ASCORBYL METHYLSILANOL PECTINATE (UNII: M3PF9237YC)
EDETATE TRISODIUM (UNII: 420IP921MB)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SOYBEAN (UNII: L7HT8F1ZOD)
CERAMIDE 3 (UNII: 4370DF050B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-210-01	7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
2	NDC: 68828-210-02	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 final	part352	11/14/2014

Part 2 of 3

TIME REVEAL 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	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	BENZOIC ACID (UNII: 8SKN0B0MIM)
INGR	DEHYDROACETIC ACID (UNII: 2KAG279R6R)
INGR	SODIUM CHLORIDE (UNII: 451W47IQ8X)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	GLYCOLIC ACID (UNII: 0WT12SX38S)
INGR	GLYCOL STEARATE (UNII: 0324G66D0E)
INGR	ETHYLHEXYL PALMITATE (UNII: 2865993309)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	ALLANTOIN (UNII: 344S277G0Z)
INGR	SALICYLIC ACID (UNII: O414PZ4LPZ)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
INGR	CITRAL (UNII: T7EU0O9VPP)
INGR	LIMONENE, (+)- (UNII: GFD7C86Q1W)
INGR	.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
INGR	HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
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

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

Part 3 of 3

TIME DELAY 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	CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
INGR	PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)
INGR	ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
INGR	POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
INGR	C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
INGR	LAURETH-7 (UNII: Z95S6G8201)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	GLYCOPROTEIN HORMONES ALPHA POLYPEPTIDE (UNII: QAF8Z6N25M)
INGR	YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
INGR	ALEURITIC ACID (UNII: 4ZK9T6U1F5)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	CARBOMER 934 (UNII: Z135WT9208)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	ISOSTEARYL BEHENATE (UNII: NA95U012OW)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	CYCLOMETHICONE (UNII: NMQ347994Z)
INGR	LEMON PEEL (UNII: 72O054U628)
INGR	HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
INGR	DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
INGR	DMDM HYDANTOIN (UNII: BYR0546TOW)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	CETYL ALCOHOL (UNII: 936JST6JCN)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	ENGLISH WALNUT (UNII: 1V3SHR7QB7)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	PEG-4 LAURATE (UNII: AYF4VM3N1Z)
INGR	IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
INGR	EDETATE TRISODIUM (UNII: 420IP921MB)
INGR	DIMETHYLSILANOL HYALURONATE (UNII: Z853O1D4TE)
INGR	ISOCETYL ALCOHOL (UNII: 1800H64066)
INGR	CERAMIDE 3 (UNII: 4370DF050B)
INGR	ASCORBYL METHYLSILANOL PECTINATE (UNII: M3PF9237YC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		7.4 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	11/30/2014

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(68828-209, 68828-210)