TEA BLEND SAMPLES JAFRA- avobenzone, octinoxate, octisalate   
JAFRA COSMETICS INTERNATIONAL

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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Tea Blend Kit

Active ingredients purpose

Avobenzone 2.5% Sunscreen

Octinoxate 7.5% Sunscreen

Octisalate 5% Sunscreen

Uses

helps prevent sunburn

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.

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 product 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, Polyglyceryl-3 Methylglucose Distearate, polyacrylamide, C13-14 Isoparaffin, Laureth-7, Glycerin, Glyceryl Stearate, Saccharide Isomerate, Fragrance/Parfum, Carica Papaya Extract, Glycyrrhiza Glabra (Licorice) Extract, Panthenol, Tocopheryl Acetate. Camellia Sinensis Leaf Extract, Trisodium EDTA, Ethylhexylglycerin, Methylisothiazolinone.

carton back

carton front

Tea Blend

Tester

Contains: 3 samples

1 Daily Moisturizer Broad Spectrum SPF 15/1 Nightly Moisturizer/ 1 Cleanser + Toner

Cont. Net. 22,5 ml .76 Fl Oz (US)

TEA BLEND SAMPLES  JAFRA
avobenzone, octinoxate, octisalate kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-119
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68828-119-01 1 in 1 KIT
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 TUBE 7.5 mL
Part 2 1 TUBE 7.5 mL
Part 3 1 TUBE 7.5 mL
Part 1 of 3
DAILY MOISTURIZER BROAD SPECTRUM SPF 15  JAFRA
avobenzone, octinoxate, octisalate cream
Product Information
Item Code (Source) NDC:68828-120
Route of Administration TOPICAL DEA Schedule     
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 5 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAURETH-7 (UNII: Z95S6G8201)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
LICORICE (UNII: 61ZBX54883)  
PANTHENOL (UNII: WV9CM0O67Z)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68828-120-01 7.5 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 01/18/2013
Part 2 of 3
CLEANSER AND TONER  JAFRA
body and hand (excluding shaving preparations)
Product Information
Other Ingredients
Ingredient Kind Ingredient Name Quantity
INGR WATER (UNII: 059QF0KO0R)  
INGR SODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)  
INGR SODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5)  
INGR SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
INGR PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)  
INGR PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
INGR SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
INGR DMDM HYDANTOIN (UNII: BYR0546TOW)  
INGR IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
INGR ALLANTOIN (UNII: 344S277G0Z)  
INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
INGR GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
INGR PAPAYA (UNII: KU94FIY6JB)  
INGR LICORICE (UNII: 61ZBX54883)  
INGR EDETATE SODIUM (UNII: MP1J8420LU)  
INGR PANTHENOL (UNII: WV9CM0O67Z)  
INGR PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
INGR HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 7.5 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 01/18/2013
Part 3 of 3
NIGHTLY MOISTURIZER  JAFRA
face and neck (excluding shaving preparations)
Product Information
Other Ingredients
Ingredient Kind Ingredient Name Quantity
INGR WATER (UNII: 059QF0KO0R)  
INGR C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)  
INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
INGR GLYCERIN (UNII: PDC6A3C0OX)  
INGR CETYL ALCOHOL (UNII: 936JST6JCN)  
INGR SHEA BUTTER (UNII: K49155WL9Y)  
INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGR CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
INGR SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
INGR CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
INGR CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
INGR SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
INGR PAPAYA (UNII: KU94FIY6JB)  
INGR LICORICE (UNII: 61ZBX54883)  
INGR DMDM HYDANTOIN (UNII: BYR0546TOW)  
INGR VERBENA OFFICINALIS (UNII: QT8A71T9BM)  
INGR XANTHAN GUM (UNII: TTV12P4NEE)  
INGR PANTHENOL (UNII: WV9CM0O67Z)  
INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGR GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
INGR EDETATE TRISODIUM (UNII: 420IP921MB)  
INGR PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
INGR IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 7.5 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 01/21/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 01/18/2013
Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)
Establishment
Name Address ID/FEI Business Operations
Jafra Manufacturing, S.A. de C.V. 814732061 manufacture(68828-119, 68828-120)

Revised: 1/2013
Document Id: b3330ad8-065f-4d6c-8bbc-d3485443716a
Set id: 839851fb-a743-478c-90e3-125d59027847
Version: 1
Effective Time: 20130118
 
JAFRA COSMETICS INTERNATIONAL