BRIGHTENING DYNAMICS TRAVELING KIT JAFRA- octinoxate, zinc oxide

United States - English - NLM (National Library of Medicine)

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Active ingredient:
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
Available from:
Jafra Cosmetics International Inc
Prescription type:
OTC DRUG
Authorization status:
OTC monograph final
Authorization number:
68828-203-01, 68828-207-01

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

BRIGHTENING DYNAMICS TRAVELING KIT JAFRA

octinoxate, zinc oxide kit

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 8 28 -20 3

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 8 28 -20 3-0 1

1 in 1 KIT; Type 0 : No t a Co mbinatio n Pro duct

12/14/20 14

Quantity of Parts

Part #

Package Quantity

Total Product Quantity

Pa rt 1

1 TUBE

7.5 mL

Pa rt 2

1 BAG

6 g

Pa rt 3

1 BOTTLE

25 mL

Part 1 of 3

BRIGHTENING BROAD SPECTRUM SPF 15 JAFRA

octinoxate, zinc oxide lotion

Product Information

Ite m Code (Source )

NDC:6 8 8 28 -20 7

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

5.0 g in 10 0 mL

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

ZINC OXIDE

3.9 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

TRIDECYL NEO PENTANO ATE (UNII: 3Z8 H1DA7J5)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

PO LYACRYLAMIDE ( 10 0 0 0 MW) (UNII: E2KR9 C9 V2I)

C13 -14 ISO PARAFFIN (UNII: E4F12ROE70 )

DULSE (UNII: 78 32HOY4ZQ)

CYCLO METHICO NE (UNII: NMQ3479 9 4Z)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

DMDM HYDANTO IN (UNII: BYR0 546 TOW)

IO DO PRO PYNYL BUTYLCARBAMATE (UNII: 6 0 3P14DHEB)

LICO RICE (UNII: 6 1ZBX548 8 3)

PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576 )

BIO SACCHARIDE GUM-4 (UNII: 9 XRL0 57X9 0 )

CHO NDRUS CRISPUS CARRAGEENAN (UNII: UE8 56 F2T78 )

PANTHENO L (UNII: WV9 CM0 O6 7Z)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

XANTHAN GUM (UNII: TTV12P4NEE)

EDETATE TRISO DIUM (UNII: 420 IP9 21MB)

BENZYL BENZO ATE (UNII: N8 6 3NB338 G)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 8 8 28 -20 7-0 1

7.5 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt352

11/14/20 14

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, CO RN (UNII: O8 232NY3SJ)

INGR

SO DIUM LAURO YL GLUTAMATE (UNII: NCX1UU2D33)

INGR

SO DIUM CO CO YL ISETHIO NATE (UNII: 518 XTE8 49 3)

INGR

SO RBITO L (UNII: 50 6 T6 0 A25R)

INGR

ALUMINUM STARCH O CTENYLSUCCINATE (UNII: I9 PJ0 O6 29 4)

INGR

MAGNESIUM CARBO NATE (UNII: 0 E53J9 27NA)

INGR

HYDRO XYPRO PYL GUAR ( 2 50 0 -4 50 0 MPA.S AT 1%) (UNII: 3A1I7376 TC)

INGR

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

INGR

MACRO CYSTIS PYRIFERA (UNII: K31S3OG5C4)

INGR

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

INGR

PEARL ( HYRIO PSIS CUMINGII) (UNII: A75L5FZ40 U)

INGR

HYDRATED SILICA (UNII: Y6 O7T4G8 P9 )

INGR

DMDM HYDANTO IN (UNII: BYR0 546 TOW)

INGR

IO DO PRO PYNYL BUTYLCARBAMATE (UNII: 6 0 3P14DHEB)

INGR

METHYLPARABEN (UNII: A2I8 C7HI9 T)

INGR

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

INGR

LINALO O L, ( +) - (UNII: F4VNO44C0 9 )

INGR

BENZYL BENZO ATE (UNII: N8 6 3NB338 G)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

6 g in 1 BAG; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

Co sme tic

12/14/20 14

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: 0 59 QF0 KO0 R)

INGR

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

INGR

SO DIUM PYRRO LIDO NE CARBO XYLATE (UNII: 46 9 OTG57A2)

INGR

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

INGR

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

INGR

IO DO PRO PYNYL BUTYLCARBAMATE (UNII: 6 0 3P14DHEB)

INGR

PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)

INGR

PANTHENO L (UNII: WV9 CM0 O6 7Z)

INGR

ALLANTO IN (UNII: 344S277G0 Z)

INGR

EDETATE SO DIUM (UNII: MP1J8 420 LU)

INGR

LICO RICE (UNII: 6 1ZBX548 8 3)

INGR

PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576 )

INGR

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

INGR

DULSE (UNII: 78 32HOY4ZQ)

INGR

BENZYL BENZO ATE (UNII: N8 6 3NB338 G)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

25 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

Co sme tic

12/14/20 14

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt352

12/14/20 14

Jafra Cosmetics International Inc

Labeler -

Jafra Cosmetics International Inc (041676479)

Registrant -

Jafra Cosmetics International Inc (041676479)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Jafra Manufacturing, S.A. de C.V.

8 147320 6 1

manufacture(6 8 8 28 -20 3, 6 8 8 28 -20 7)

Revised: 5/2019

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