Label: TONYMOLY MY SUNNY WATERPROOF SUN BLOCK- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 59078-108-02 - Packager: Tonymoly 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 February 2, 2016
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Use
- Caution
- Keep out of reach of children
- Directions
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Inactive Ingredients
WATER, CYCLOPENTASILOXANE, PEG-10 DIMETHICONE, BUTYLOCTYL SALICYLATE, DICAPRYLYL CARBONATE, BIOSACCHARIDE GUM-1, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, METHYL METHACRYLATE CROSSPOLYMER, METHICONE, PORTULACA OLERACEA EXTRACT, ALUMINUM HYDROXIDE, DIMETHICONE, PHENOXYETHANOL, CALCIUM ALUMINUM BOROSILICATE, FRAGRANCE, STEARIC ACID, CAPRYLYL GLYCOL, GLYCERYL CAPRYLATE, POLYGLYCERYL-6 POLYRICINOLEATE, TOCOPHERYL ACETATE, MICROCRYSTALLINE CELLULOSE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, CHAMAECYPARIS OBTUSA LEAF EXTRACT, ORIGANUM VULGARE LEAF EXTRACT, SALIX ALBA (WILLOW) BARK EXTRACT, CELLULOSE GUM, CINNAMOMUM CASSIA BARK EXTRACT, LACTOBACILLUS/SOYBEAN FERMENT EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, NYMPHAEA ALBA FLOWER EXTRACT, ALOE BARBADENSIS LEAF JUICE, GLYCERYL POLYMETHACRYLATE, PROPYLENE GLYCOL, PLATINUM POWDER, POLYSORBATE 80
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INGREDIENTS AND APPEARANCE
TONYMOLY MY SUNNY WATERPROOF SUN BLOCK
suntan gels, creams, and liquids creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59078-108 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 8.064 g in 60 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.106 g in 60 g Inactive Ingredients Ingredient Name Strength WILLOW BARK (UNII: S883J9JDYX) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PORTULACA OLERACEA WHOLE (UNII: D5J3623SV2) CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) WATER (UNII: 059QF0KO0R) POLYSORBATE 80 (UNII: 6OZP39ZG8H) MAGNESIUM SULFATE (UNII: DE08037SAB) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) PHENOXYETHANOL (UNII: HIE492ZZ3T) STEARIC ACID (UNII: 4ELV7Z65AP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59078-108-02 1 in 1 CARTON 01/14/2016 1 60 g in 1 TUBE; 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 01/14/2016 Labeler - Tonymoly Co., Ltd. (688216798) Registrant - Tonymoly Co., Ltd. (688216798) Establishment Name Address ID/FEI Business Operations Kolmar 688732723 manufacture(59078-108)
