BRIGHTENING DYNAMICS TRAVELING KIT JAFRA- octinoxate, zinc oxide kit

Brightening Dynamics Traveling Kit by

Drug Labeling and Warnings

Brightening Dynamics Traveling 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

Octinioxate 5% Sunscreen

Zinc Oxide 3.9% 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, Dimethicone, Tridecyl Neopentanoate, Glyceryl Stearate, PEG-100 Stearate, Glycerin, Polyacrylamide, C13-14 Isoparaffin, Laureth-7 Palmaria Palmata (red seaweed) Extract, Acrylates Copolymer, Cyclomethicone, Cetyl Alcohol, DMDM Hydantoin, Iodopropyl Butylcarbamate, Glycyrrhiza Glabra (Licorice) Extract, Phyllanthus Emblica Extract, Withania Somnifera (Winter Cherry) Extract, Biosaccharide Gum-4, Chondrus Crispus (Carrageenan) Extract, Smithsonite Extract, Panthenol, Tocopheryl Acetate, Xanthan Gum, Fragrance/parfum, Trisodium EDTA, Benzyl Benzoate

PRINCIPAL DISPLAY PANEL

Jafra

Brightening Dyamic Kit

Brightening Lotion Broad Spectrum SPF 15
7.5 ml 25 FL OZ

INGREDIENTS AND APPEARANCE

BRIGHTENING DYNAMICS TRAVELING KIT  JAFRA
octinoxate, zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-203

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-203-01	1 in 1 KIT; Type 0: Not a Combination Product	12/14/2014

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	7.5 mL
Part 2	1 BAG	6 g
Part 3	1 BOTTLE	25 mL

Part 1 of 3

BRIGHTENING BROAD SPECTRUM SPF 15  JAFRA
octinoxate, zinc oxide lotion

Product Information
Item Code (Source)	NDC: 68828-207
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5.0 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3.9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
DULSE (UNII: 7832HOY4ZQ)
CYCLOMETHICONE (UNII: NMQ347994Z)
CETYL ALCOHOL (UNII: 936JST6JCN)
DMDM HYDANTOIN (UNII: BYR0546TOW)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
LICORICE (UNII: 61ZBX54883)
PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE TRISODIUM (UNII: 420IP921MB)
BENZYL BENZOATE (UNII: N863NB338G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-207-01	7.5 mL in 1 TUBE; Type 0: Not a Combination Product

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

REVITALIZING PEARL CLEANSER  JAFRA
body and hand (excluding shaving preparations)

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	STARCH, CORN (UNII: O8232NY3SJ)
INGR	SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
INGR	SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
INGR	SORBITOL (UNII: 506T60A25R)
INGR	ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
INGR	MAGNESIUM CARBONATE (UNII: 0E53J927NA)
INGR	HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)
INGR	ALOE VERA LEAF (UNII: ZY81Z83H0X)
INGR	MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U)
INGR	HYDRATED SILICA (UNII: Y6O7T4G8P9)
INGR	DMDM HYDANTOIN (UNII: BYR0546TOW)
INGR	IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
INGR	METHYLPARABEN (UNII: A2I8C7HI9T)
INGR	PROPYLPARABEN (UNII: Z8IX2SC1OH)
INGR	LINALOOL, (+)- (UNII: F4VNO44C09)
INGR	BENZYL BENZOATE (UNII: N863NB338G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		6 g in 1 BAG; Type 0: Not a Combination Product

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

Part 3 of 3

BRIGHTENING TONER  JAFRA
body and hand (excluding shaving preparations)

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	ALCOHOL (UNII: 3K9958V90M)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
INGR	DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
INGR	IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	ALLANTOIN (UNII: 344S277G0Z)
INGR	EDETATE SODIUM (UNII: MP1J8420LU)
INGR	LICORICE (UNII: 61ZBX54883)
INGR	PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	DULSE (UNII: 7832HOY4ZQ)
INGR	BENZYL BENZOATE (UNII: N863NB338G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		25 mL in 1 BOTTLE; Type 0: Not a Combination Product

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(68828-203, 68828-207)