TEA BLEND SAMPLES JAFRA- avobenzone, octinoxate, octisalate kit

Tea Blend Samples by

Drug Labeling and Warnings

Tea Blend Samples by is a Otc medication manufactured, distributed, or labeled by JAFRA COSMETICS INTERNATIONAL, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

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)

INGREDIENTS AND APPEARANCE

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; Type 0: Not a Combination Product	01/21/2013

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

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; Type 0: Not a Combination Product

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; Type 0: Not a Combination Product

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; Type 0: Not a Combination Product

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)