Label: SIORISYOU ARE MY SHINING SUNSCREEN- zinc oxide, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 73495-020-01, 73495-020-02 - Packager: Zenkosmetikos Co., Ltd.
- 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 December 24, 2019
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredients:
Prunus Mume Fruit Water, Dicaprylyl Cabonate, Isoamyl Laurate, Caprylic/Capric Triglyceride, Polyglyceryl-3 Ricinoleate, Bees- wax, Silica, Persea Gratissima (Avocado) Oil, Glycerin, Sorbitan Isostearate, Water, Sodium Chloride, Artemisia Montana Leaf Extract, Ginkgo Biloba Leaf Extract, Centella Asiatica Extract, Vaccinium Corymbosum (Blueberry) Fruit, Rosa Canina Fruit Oil, Scutellaria Baicalensis Root Extract, Paeonia Suffruticosa Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Sodium PCA, (-)-alpha-bisabolol, Tocopherol, Butylene Glycol, Stearic Acid, Aluminum Hydroxide, Citric Acid, Pelargonium Graveolens Flower Oil. Citrus Aurantium Dulcis (Orange) Peel Oil, Amyris Balsamifera Bark Oil, Helianthus Annuus (Sunflower) Seed Oil
- PURPOSE
- WARNINGS
- DESCRIPTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SIORISYOU ARE MY SHINING SUNSCREEN
zinc oxide, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73495-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 4.84 g in 30 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 1.49 g in 30 mL Inactive Ingredients Ingredient Name Strength PRUNUS MUME FRUIT OIL (UNII: I4HW888TQ6) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73495-020-02 1 in 1 CARTON 12/20/2019 1 NDC:73495-020-01 30 mL 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 12/20/2019 Labeler - Zenkosmetikos Co., Ltd. (694793999) Registrant - Zenkosmetikos Co., Ltd. (694793999) Establishment Name Address ID/FEI Business Operations Elan Cosmetic Co.,ltd 688204926 manufacture(73495-020)