Label: SRB 3 LIGHTING WHITE BB- titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70218-020-01 - Packager: CASINBIO CO., LTD.
- Category: HUMAN OTC DRUG LABEL
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 November 12, 2015
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients: Water, Cyclopentasiloxane, Isododecane, Dipropylene Glycol, Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone, Polymethylsilsesquioxane, Silica, Phenyl Trimethicone, Niacinamide, Sodium Chloride, Iron Oxides (CI 77492), Disteardimonium Hectorite, Methyl Trimethicone, Oryza Sativa (Rice) Bran Extract, Sorbitan Isostearate, Calcium Stearate, Triethoxycaprylylsilane, Triethyl Citrate, Iron Oxides (CI 77491), Hydrogen Dimethicone, Phenoxyethanol, Caprylyl Glycol, Iron Oxides (CI 77499), Fragrance, Dextrin Ethylhexylglycerin, 1,2-Hexanediol, Adenosine, Disodium EDTA, Butylene Glycol, Citrus Aurantifolia (Lime) Flower Extract, Prunus Persica (Peach) Flower Extract, Propylene Glycol, Pyrus Malus (Apple) Flower Extract, Arnica Montana Flower Extract, Ananas sativus (pineapple) fruit Extract, Alchemilla Vulgaris Extract, Actinidia Chinensis (Kiwi) Fruit Extract, Olea Europaea (Olive) Leaf Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Equisetum Arvense Extract, Adansonia Digitata Seed Extract, Punica Granatum Flower Extract, Prunus Avium (Sweet Cherry) Flower Extract, Citrus Aurantium Dulcis (Orange) Flower Extract, Fructan, Sophora Japonica Flower Extract
- PURPOSE
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WARNINGS
Warnings: 1. If the following side effects occur, immediately discontinue use. Before resuming use, consult a dermatologist as continual use may worsen symptoms. A) If red spots, swelling, itching, irritation, or other discomforts occur after using the product. B) If the above symptoms occur on the applied area after exposure to direct sunlight. 2. Do not use on open wounds or on areas of skin exhibiting signs of eczema or dermatitis. 3. Storage and handling precautions A) Keep product out of reach of infants and children. B) Ensure that lid is closed after use. C) Do not store in places subject to high or cold temperatures or under exposure to direct sunlight. D) Use care to avoid eye contact when using this product.
- DESCRIPTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SRB 3 LIGHTING WHITE BB
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70218-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 3.80 g in 35 g Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 2.01 g in 35 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Isododecane (UNII: A8289P68Y2) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70218-020-01 35 g 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 10/01/2015 Labeler - CASINBIO CO., LTD. (557830673) Registrant - CASINBIO CO., LTD. (557830673) Establishment Name Address ID/FEI Business Operations CASINBIO CO., LTD. 557830673 repack(70218-020) Establishment Name Address ID/FEI Business Operations Cosmecca Korea Co., Ltd. 688830827 manufacture(70218-020)
