BRIGHTENING HAND BROAD SPECTRUM SPF 20 JAFRA- avobenzone, octinoxate, octisalate, octocrylene cream

Brightening Hand Broad Spectrum SPF 20 by

Drug Labeling and Warnings

Brightening Hand Broad Spectrum SPF 20 by is a Otc medication manufactured, distributed, or labeled by Jafra Cosmetics International Inc, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients              Purpose

Avobenzone 3%                Sunscreen

Octinoxate 7.5%               Sunscreen

Octisalate 5%                  Sunscreen

Octocrylene 7%                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 right away.

When using this product, keep out of eyes. Rinse with water to remove.

Warnings

For external use only

Do not use on damaged or broken skin.
Stop use and and ask a doctor if rash occurs

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 am to 2 pm

wear long-sleeve shirts, pants hats, and sunglasses

Inactive Ingredients

Water/aqua, Sodium polyacrylate, Butyrospermum parkii (Shea Butter) Fruit, Decamethylcyclopentasiloxane, Fragrance/Parfum, Pentylene Glycol, Bis-Diglyceryl Polyacyladipate-2, Cetyl alcohol, Glycerin, Lecithin, Citrus Paradisi (Grapefruit) Fruit Extract, Citrus Aurantium Amara (Bitter Orange) Fruit Extract, Sodium Ascorbate, Tocopherol, Helianthus Annuus (Sunflower) Seed Oil, Panthenol, Tocopheryl Acetate, Ethylhexylglycerin, Methylisothiazolinone,Trisodium EDTA, Allantoin, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Retinyl Palmitate, Palmaria Palmata (Red Seaweed) Extract, Glycyrrhiza Glabra (Licorice) Extract, Phyllanthus Emblica Extract, Withania Somniferia (winter cherry) Extract

PRINCIPAL DISPLAY PANEL

fra Brightening

Brightening Hand Cream
Broad Spectrum SPF 20

75 ml 2.5 Fl. Oz. (US)

INGREDIENTS AND APPEARANCE

BRIGHTENING HAND BROAD SPECTRUM SPF 20  JAFRA
avobenzone, octinoxate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-091
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
GRAPEFRUIT (UNII: O82C39RR8C)
SODIUM ASCORBATE (UNII: S033EH8359)
TOCOPHEROL (UNII: R0ZB2556P8)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
EDETATE TRISODIUM (UNII: 420IP921MB)
ALLANTOIN (UNII: 344S277G0Z)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
LICORICE (UNII: 61ZBX54883)
PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-091-01	1 in 1 BOX	05/30/2012
1	NDC: 68828-091-02	75 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/30/2012

Labeler - Jafra Cosmetics International Inc (041676479)

Registrant - Jafra Cosmetics International Inc (041676479)

Establishment
Name	Address	ID/FEI	Business Operations
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture(68828-091)