OTC Medication Information: AGELESS Total Rejuvenating Hand

AGELESS TOTAL REJUVENATING HAND — octinoxate, octisalate, avobenzone and 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.

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
(click image for full-size original)
AGELESS TOTAL REJUVENATING HAND
octinoxate, octisalate, avobenzone, octocrylene cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4036
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 75 mg in 1 mL
OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE 20 mg in 1 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 20 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62742-4036-1 56.7 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 01/01/2010
Labeler — Allure Labs, Inc. (926831603)

Revised: 07/2010 Allure Labs, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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