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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:68828-119
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-119-011 in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 7.5 mL
Part 21 TUBE 7.5 mL
Part 31 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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE2.5 g  in 100 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
POLYACRYLAMIDE (1500 MW) 
C13-14 ISOPARAFFIN 
LAURETH-7 
GLYCERIN 
GLYCERYL MONOSTEARATE 
SACCHARIDE ISOMERATE 
LICORICE 
PANTHENOL 
.ALPHA.-TOCOPHEROL ACETATE 
GREEN TEA LEAF 
EDETATE TRISODIUM 
ETHYLHEXYLGLYCERIN 
METHYLISOTHIAZOLINONE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-120-017.5 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/18/2013
Part 2 of 3
CLEANSER AND TONER  JAFRA
body and hand (excluding shaving preparations)
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER 
INGRSODIUM COCOYL GLYCINATE 
INGRSODIUM LAUROYL OAT AMINO ACIDS 
INGRSODIUM C14-16 OLEFIN SULFONATE 
INGRCOCAMIDOPROPYL BETAINE 
INGRPEG-150 PENTAERYTHRITYL TETRASTEARATE 
INGRPEG-8 DIMETHICONE 
INGRSACCHARIDE ISOMERATE 
INGRDMDM HYDANTOIN 
INGRIODOPROPYNYL BUTYLCARBAMATE 
INGRALLANTOIN 
INGRCITRIC ACID MONOHYDRATE 
INGRGREEN TEA LEAF 
INGRPAPAYA 
INGRLICORICE 
INGREDETATE SODIUM 
INGRPANTHENOL 
INGRPROPYLENE GLYCOL 
INGRHAMAMELIS VIRGINIANA TOP 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
17.5 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/18/2013
Part 3 of 3
NIGHTLY MOISTURIZER  JAFRA
face and neck (excluding shaving preparations)
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER 
INGRC10-18 TRIGLYCERIDES 
INGRMEDIUM-CHAIN TRIGLYCERIDES 
INGRGLYCERIN 
INGRCETYL ALCOHOL 
INGRSHEA BUTTER 
INGRGLYCERYL MONOSTEARATE 
INGRCETOSTEARYL ALCOHOL 
INGRSODIUM STEAROYL LACTYLATE 
INGRCELLULOSE, MICROCRYSTALLINE 
INGRCARBOXYMETHYLCELLULOSE SODIUM 
INGRSACCHARIDE ISOMERATE 
INGRPAPAYA 
INGRLICORICE 
INGRDMDM HYDANTOIN 
INGRVERBENA OFFICINALIS 
INGRXANTHAN GUM 
INGRPANTHENOL 
INGR.ALPHA.-TOCOPHEROL ACETATE 
INGRGREEN TEA LEAF 
INGREDETATE TRISODIUM 
INGRPEG-4 LAURATE 
INGRIODOPROPYNYL BUTYLCARBAMATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
17.5 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/21/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/18/2013
Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Jafra Manufacturing, S.A. de C.V.814732061manufacture(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