Label: LONG WEAR GET OVER BB- titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69739-020-01 - Packager: 1004LABORATORY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated April 24, 2015
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients: Glycyrrhiza Glabra (Licorice) Root Water, Camellia Sinensis Leaf Water, Aloe Barbadensis Leaf Water, Coco-Caprylate/Caprate, Dicaprylyl Carbonate, Polyglyceryl-3 Diisostearate, Glycerin, Isoamyl Laurate, Polyglyceryl-2 Dipolyhydroxyste arate, Sodium Chloride, Calen dula Officinalis Flower Extract, Sorbitan Olivate, NelumboNu cifera Flower Water, Centaurea Cyanus Flower Water, Lacto bacillus/Hibiscus Sabdariffa Flower Ferment Filtrate, Rosa Centifolia Flower Water, Zant hoxylum Piperitum Fruit Ext ract, Pulsatilla Koreana Extract, Usnea Barbata (Lichen) Extract, Cocos Nucifera (Coco nut) Oil, Hippophae Rham no ides Seed Oil, Voacanga Afri cana Seed Extract, Rosa Cani na Fruit Extract, Yellow Oxide of Iron, alpha-bisabolol, Water, Morus Alba Bark Extract, Saccharomyces/Caragana Sinica Root Ferment Extract, Glycine Max (Soybean) Seed Extract, Chamomilla Recutita (Ma tricaria) Flower/Leaf Extract, Rosmarinus Officinalis (Rosemary) Extract, Lavandula Angustifolia (Lavender) Extract, Monarda Didyma Leaf Extract, Ocimum Basilicum (Basil) Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Origanum Vulg are Leaf Extract, Mentha Viri dis (Spearmint) Extract, Melissa Officinalis Extract, Ethyl Ferulate, Oenothera Biennis (Evening Primrose) Oil, Borago Officinalis Seed Oil, Pistacia Vera Seed Oil, Red Oxide of Iron, Glyceryl Caprylate, Aluminum Hydroxide, stearic Acid, Citrus Aurantium Dulcis (Orange) Oil, Glycyrrhiza Glabra (Licorice) Root Extract, Rhodiola Rosea Root Extract, Rosa Damascena Flower Extract, Taraxacum Offi cinale (Dandelion) Leaf Extract, Olea Europaea (Olive) Leaf Extract, Mangifera Indica (Mango) Seed Butter, Argania Spinosa Kernel Oil, Black Oxide of Iron, Lavandula Angustifolia(Lavender) Oil, Adenosine
- PURPOSE
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WARNINGS
Warnings: 1. Stop using the product if the following problems arise while using the product as continued use could worsen the symptoms; consult with a dermatologist. A. If red spots, swelling, itchiness, and irritation occur. B. If the above problems occur on the applied area on the skin from direct sunlight 2. Do not use on areas with wounds, eczema, and dermatitis. 3. Storage and handling precautions A. Close the lid after use. B. Keep away from the reach of babies and children. C. Do not store in high-temperature or low-temperature and keep away from direct sunlight 4. Wash off the product if it gets in the eye
- DESCRIPTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LONG WEAR GET OVER BB
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69739-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 3.37 mg in 30 mL Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 1.47 mg in 30 mL Inactive Ingredients Ingredient Name Strength Licorice (UNII: 61ZBX54883) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69739-020-01 30 mL in 1 CARTON; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/01/2015 Labeler - 1004LABORATORY (689512629) Registrant - 1004LABORATORY (689512629) Establishment Name Address ID/FEI Business Operations 1004LABORATORY 689512629 manufacture(69739-020)
