BRIGHTENING DYNAMICS TRAVELING KIT JAFRA- octinoxate, zinc oxide 
Jafra Cosmetics International Inc

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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Brightening Dynamics Traveling Kit

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

Jafra

Brightening Dyamic Kit

Brightening Lotion Broad Spectrum SPF 15
7.5 ml 25 FL OZ

image of carton back

BRIGHTENING DYNAMICS TRAVELING KIT  JAFRA
octinoxate, zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-203
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-203-011 in 1 KIT; Type 0: Not a Combination Product12/14/201401/01/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 7.5 mL
Part 21 BAG 6 g
Part 31 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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.9 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-207-017.5 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/14/201401/01/2021
Part 2 of 3
REVITALIZING PEARL CLEANSER  JAFRA
body and hand (excluding shaving preparations) cream
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRSTARCH, CORN (UNII: O8232NY3SJ)  
INGRSODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)  
INGRSODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
INGRSORBITOL (UNII: 506T60A25R)  
INGRALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
INGRMAGNESIUM CARBONATE (UNII: 0E53J927NA)  
INGRHYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
INGRMACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGRPEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U)  
INGRHYDRATED SILICA (UNII: Y6O7T4G8P9)  
INGRDMDM HYDANTOIN (UNII: BYR0546TOW)  
INGRIODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
INGRLINALOOL, (+)- (UNII: F4VNO44C09)  
INGRBENZYL BENZOATE (UNII: N863NB338G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
16 g in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic12/14/201401/01/2021
Part 3 of 3
BRIGHTENING TONER  JAFRA
body and hand (excluding shaving preparations) cream
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRALCOHOL (UNII: 3K9958V90M)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGRPROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
INGRDIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
INGRIODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRALLANTOIN (UNII: 344S277G0Z)  
INGREDETATE SODIUM (UNII: MP1J8420LU)  
INGRLICORICE (UNII: 61ZBX54883)  
INGRPHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)  
INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
INGRDULSE (UNII: 7832HOY4ZQ)  
INGRBENZYL BENZOATE (UNII: N863NB338G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
125 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic12/14/201401/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/14/201401/01/2021
Labeler - Jafra Cosmetics International Inc (041676479)
Registrant - Jafra Cosmetics International Inc (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-203, 68828-207)

Revised: 1/2021
Document Id: b8b85fa9-55f7-3eca-e053-2995a90a0c80
Set id: f4a264f7-95c5-4d6c-aaa7-f3749719cf96
Version: 17
Effective Time: 20210112
 
Jafra Cosmetics International Inc