Label: W LAB BLOSSOM WHITE CUSHION 13 BLOSSOM WHITE- titanium dioxide, octinoxate, octisalate, octocrylene, zinc oxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 69894-460-01, 69894-460-02 - Packager: WOW VENTURES
- 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 October 28, 2016
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients: Rosa Damascena Flower Water, Butylene Glycol, Cyclopentasiloxane, Cyclohexasiloxane, Glycerin, C12-15 Alkyl benzoate, PEG-30 Dipolyhydroxystearate, Niacinamide, Trimethylsiloxysilicate, PEG-10 Dimethicone, Sodium Chloride, Quaternium-18 Bentonite, Dimethicone, Iron Oxides (CI 77492), Ozokerite, Copernicia Cerifera (Carnauba) Wax, Triethoxycaprylylsilane, Chlorphenesin, Iron Oxides (CI 77491), Aluminum Hydroxide (CI 77002), Phenoxyethanol, Perfume, Water, Iron Oxides (CI 77499), Adenosine, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Trehalose, Melaleuca Alternifolia (Tea Tree) Leaf Water, Rubus Idaeus (Raspberry) Fruit Extract, Oenothera Biennis (Evening Primrose) Flower Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Bambusa Vulgaris Water, Lilium Candidum Bulb Extract, Xylitylglucoside, Propanediol, Rosmarinus Officinalis (Rosemary) Leaf Water, Propylene Glycol, Melissa Officinalis Flower/Leaf/Stem Water, Anhydroxylitol, Alcohol, Xylitol, Origanum Majorana Leaf Extract, Leontopodium Alpinum Extract, 1,2-Hexanediol, Lavandula Angustifolia (Lavender) Flower, Phyllanthus Emblica Fruit Extract, Angelica Archangelica Root Extract, Centella Asiatica Extract, Salicornia Herbacea Extract, Gentiana Lutea Root Extract, Achillea Millefolium Extract, Artemisia Vulgaris Extract, Arnica Montana Flower Extract, Portulaca Oleracea Extract, Chamomilla Recutita (Matricaria) Flower Extract, Vitex Agnus Castus Extract, Plankton Extract, Camellia Japonica Flower Extract, Viola Tricolor Extract, Rubus Fruticosus (Blackberry) Fruit Extract, Potassium Sorbate, Sodium Hyaluronate, Citric Acid, Sodium Benzoate, Euterpe Oleracea Fruit Extract, Arginine Ferulate, Calendula Officinalis Flower Extract, Hydrolyzed Hyaluronic Acid
- PURPOSE
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WARNINGS
Warnings: 1. Stop using the product if there is any of the following abnormal symptoms appeared after use and consult with your dermatologist as continued use can worsen the symptoms. A) if there are red spots, swelling, itchiness, or irritation B) if the above symptoms appear around the skin to which the product has been applied, after being exposed to direct sunlight. 2. Do not apply the product to any parts of the skin with wound, eczema, or dermatitis. 3. Precautions on storage and handling. A) Make sure to close the cap after use. B) Keep out of the reach of children and babies. C) Do not keep the product in a hot or cold place or a place getting direct sunlight.
- DESCRIPTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
W LAB BLOSSOM WHITE CUSHION 13 BLOSSOM WHITE
titanium dioxide, octinoxate, octisalate, octocrylene, zinc oxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69894-460 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 1.65 g in 15 g Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate 1.05 g in 15 g Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 0.72 g in 15 g Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene 0.30 g in 15 g Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 0.30 g in 15 g Inactive Ingredients Ingredient Name Strength Butylene Glycol (UNII: 3XUS85K0RA) Glycerin (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69894-460-02 1 in 1 CARTON 10/10/2016 1 NDC:69894-460-01 15 g in 1 CONTAINER; 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 10/10/2016 Labeler - WOW VENTURES (688731080) Registrant - WOW VENTURES (688731080) Establishment Name Address ID/FEI Business Operations WOW VENTURES 688731080 repack(69894-460) Establishment Name Address ID/FEI Business Operations Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory 688235645 manufacture(69894-460)
