AGELESS TOTAL REJUVENATING HAND  - octinoxate, octisalate, avobenzone, octocrylene cream 
Allure Labs, Inc.

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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Drug Facts

Active Ingredients:

1. Octinoxate (Ethylhexyl Methoxycinnamate) 7.5%

2. Octisalate (Ethylhexyl Salicylate) 5.0%

3. Butyl Methoxydibenzoylmethane (Parsol 1789, Avobenzone) 2.0%

4. Octocrylene 2.0%

Inactive Ingredients:

Water (Aqua), Caprylic/Capric Triglyceride (and) Linoleic acid (and) Glycine soja (Soybean) sterols (and) phospholepids, Caprylic/Capric Triglyceride (and) Diacetyl Boldine (Lumiskin), Kojic acid, Glycyrrhiza glabba (Licorice) root extract, Ubiquinone (Coenzyme Q10), Olea europea (Olive) leaf extract, Mushroom extract (Tricholoma matsutake singer)-enzyme-alcohol, Archtostaphylos uva ursi (Bearberry) leaf extract, Morus alba (Mulberry) leaf extract, Saccharomyces/Xylinum Black Tea Ferment-Glycerin-Hydroxyethylcellulose (Kombuchka), Dimethicone, Brassica compestris / Aleuritis fordi oil copolymer, Sodium Hyaluronate Crosspolymer, Phenoxyethanol and Caprylyl Glycol and Ethylhexyl Glycerin and Hexylene Glycol, Hydrolyzed Wheat Protein and Hydrolyzed Wheat Starch, Limnanthes alba (Meadowfoam) seed oil, PEG-60 Maracuja glycerides, Biosaccharide Gum-1, Portulac oleracea extract, Xanthan gum, Tetrahexyldecyl Ascorbate, Disodium EDTA.

Other information on back of the tube:

(Claims)

A Daily, super hydrating UVA/UVB broad spectrum moisturizer for the hands. Diminishes age spots with a blend of natural skin lightening agents, protects against harmful effects of the sun and builds up collagen to restore youthful skin. Contains eoenzyme Q10 and other anti-oxidants to fight against free radicals and environmental danmage.

Indications:

Signs of aging skin, age spots, dry, dehydrated skin.

Directions:

Apply daily for maximum protection and moisture. Reapply throughout the day and while exposed to the sun.

Reapply while exposed to Sun.

Distributor:

Image International

Palm Beach, FL 33411 USA

Image of the Product:

AGELESS Total Rejuvenating Hand Creme

Image of the Product

AGELESS TOTAL REJUVENATING HAND  
octinoxate, octisalate, avobenzone, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4036
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE20 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62742-4036-156.7 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/01/2010
Labeler - Allure Labs, Inc. (926831603)

Revised: 7/2010
Document Id: 2c2af16e-4a6c-436b-bcef-ff531e8f908f
Set id: 128658a9-f1a8-49d8-8675-c79c829f93d2
Version: 1
Effective Time: 20100701
 
Allure Labs, Inc.