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Name:No Foundation Spf 30
Manufacturer:Allure Labs, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

NO FOUNDATION SPF 30  - zinc oxide and titanium dioxide 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:

Zinc Oxide 12.2%

Titanium Dioxide 3.2%


PURPOSE:

Sunscreen


USES:

  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection

WARNINGS:

  • For external use only

WHEN USING THIS PRODUCT:

  • Keep out of eyes. Rinse with water to remove.

STOP USE AND ASK A DOCTOR IF

  • Rash or irritation develops and lasts.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.


DIRECTIONS:

  • Dr. Perricone recommends applying evenly in gentle circular motions on top of treatment and or moisturizer. Can be re-applied as necessary. Compatible with all Perricone MD products.
  • Not for use on children.

STORAGE:

  • Store at room temperature.
OTHER INFORMATION:
  • Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.
  • Lot No. and exp date: See bottom of carton.

INACTIVE INGREDIENTS:

Aqua (Water), Cyclopentasiloxane, Butylene Glycol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Tetrahexyldecyl Ascorbate, C12-15 Alkyl Benzoate, Dimethicone, Sorbitan Stearate, Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Cyclohexasiloxane, Iron Oxides (77499, 77491, 77492), Glycolic Acid, Dimethyl MEA (DMAE), Mica, Phenoxyethanol, Citric Acid, Tribehenin, Caprylyl Glycol, Lecithin, Cetyl Alcohol, Tocopheryl Linoleate/Oleate, Thioctic Acid (Alpha-Lipoic Acid), Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Hexylene Glycol, Ethylhexylglycerin, Xanthan Gum, PEG-8, Triethoxysilylethyl Polydimethylsilxyethyl Hexyl Dimethicone, Polyacrylamide, Citrus Medica Limonum (Lemon) Peel Oil, Limonene, Sodium Lactate, Ceramide-2, Aluminum Hydroxide, Stearic Acid, C13-14 Isoparaffin, PEG-10 Rapeseed Sterol, Disodium EDTA, Dipotassium Glycyrrhizate, Tocopherol, Phoenix Dactylifera (Date) Fruit Extract, Silica Dimethyl Silylate,  Teprenone, Triethoxycaprylylsilane, Linalool, Laureth-7, Silica, Ascorbyl Palmitate, Hyaluronic Acid, Ascorbic Acid, Arabidopsis Thaliana Extract, Plankton Extract, Micrococcus Lysate, Palmitoyl Oligopeptide, Salvia Sclarea (Clary) Extract, Cedrus Atlantica Bark Oil, Ilex Paraguariensis Leaf Extract, Bulnesia SarmientoiWood Oil, Coriandrm Sativum (Coriander) Fruit Oil, Salvia Sclarea (Clary) Oil, Eugenia Caryophyllus (Clove) Flower Oil, Triticum Vulgare (Wheat) Bran Extract, Anthemis Nobilis Flower Oil, Jasminum Officinale (Jasmine) Oil, Viola Odorata Flower/Leaf Extract.

DISTRIBUTOR (US):

NV Perricone LLC,

Meriden CT 06450.

DISTRIBUTOR (UK):

NV Perricone MD Cosmeceuticals LTD

London, W1S 2YE UK

www.perriconemd.com

1 888 823 7837


IMAGE OF THE PRODUCT:

Image of Product: Perricone MD No Foundation SPF30




NO FOUNDATION SPF 30 
zinc oxide and titanium dioxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62742-4047
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 122 mg  in 1 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 32 mg  in 1 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62742-4047-2 1 BOTTLE, PUMP ( BOTTLE) in 1 CARTON contains a BOTTLE, PUMP (62742-4047-1)
1 NDC:62742-4047-1 30 mL in 1 BOTTLE, PUMP This package is contained within the CARTON (62742-4047-2)

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: 08/2010 Allure Labs, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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