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 DRUGItem Code (Source)NDC:68828-119
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-119-011 in 1 KIT; Type 0: Not a Combination Product01/21/201301/01/2021
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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
WATER (UNII: 059QF0KO0R)  
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAURETH-7 (UNII: Z95S6G8201)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-120-017.5 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/18/201301/01/2021
Part 2 of 3
CLEANSER AND TONER  JAFRA
body and hand (excluding shaving preparations) liquid
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRPEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)  
INGRPEG-8 DIMETHICONE (UNII: GIA7T764OD)  
INGRSACCHARIDE ISOMERATE (UNII: W8K377W98I)  
INGRDMDM HYDANTOIN (UNII: BYR0546TOW)  
INGRIODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
INGRALLANTOIN (UNII: 344S277G0Z)  
INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
INGRGREEN TEA LEAF (UNII: W2ZU1RY8B0)  
INGRPAPAYA (UNII: KU94FIY6JB)  
INGRLICORICE (UNII: 61ZBX54883)  
INGREDETATE SODIUM (UNII: MP1J8420LU)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRPROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
INGRHAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
INGRWATER (UNII: 059QF0KO0R)  
INGRSODIUM COCOYL GLYCINATE (UNII: XLU9KH03XM)  
INGRSODIUM LAUROYL OAT AMINO ACIDS (UNII: FSW2K9B9N5)  
INGRSODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
17.5 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/18/201301/01/2021
Part 3 of 3
NIGHTLY MOISTURIZER  JAFRA
face and neck (excluding shaving preparations) cream
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRC10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)  
INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRSHEA BUTTER (UNII: K49155WL9Y)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
INGRSODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
INGRCELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
INGRCARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
INGRSACCHARIDE ISOMERATE (UNII: W8K377W98I)  
INGRPAPAYA (UNII: KU94FIY6JB)  
INGRLICORICE (UNII: 61ZBX54883)  
INGRDMDM HYDANTOIN (UNII: BYR0546TOW)  
INGRVERBENA OFFICINALIS (UNII: QT8A71T9BM)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRGREEN TEA LEAF (UNII: W2ZU1RY8B0)  
INGREDETATE TRISODIUM (UNII: 420IP921MB)  
INGRPEG-4 LAURATE (UNII: AYF4VM3N1Z)  
INGRIODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
17.5 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/21/201301/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/18/201301/01/2021
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: 1/2021
 
JAFRA COSMETICS INTERNATIONAL