Label: TONYMOLY MY SUNNY BODY AND FAMILY SUN CREAM- ethylhexyl methoxycinnamate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 59078-121-01 - Packager: Tonymoly Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 4, 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, Ethylhexyl Salicylate, PEG-10 Dimethicone, Magnesium Sulfate, Disteardimonium Hectorite, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Isoamyl p-Methoxycinnamate, Aluminum Hydroxide, Stearic Acid, Methylparaben, Chlorphenesin, Fragrance(Parfum), Caffeine, Butylene Glycol, Propylparaben, Portulaca Oleracea Extract
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INGREDIENTS AND APPEARANCE
TONYMOLY MY SUNNY BODY AND FAMILY SUN CREAM
other skin care preparations creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59078-121 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 6295 mg in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 27489 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) METHYLPARABEN (UNII: A2I8C7HI9T) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) MAGNESIUM SULFATE (UNII: DE08037SAB) CHLORPHENESIN (UNII: I670DAL4SZ) CAFFEINE (UNII: 3G6A5W338E) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) STEARIC ACID (UNII: 4ELV7Z65AP) PROPYLPARABEN (UNII: Z8IX2SC1OH) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) OCTISALATE (UNII: 4X49Y0596W) AMILOXATE (UNII: 376KTP06K8) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PORTULACA OLERACEA WHOLE (UNII: D5J3623SV2) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59078-121-01 1 in 1 CARTON 01/19/2016 1 100 mL 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 final part346 01/14/2016 Labeler - Tonymoly Co., Ltd. (688216798) Registrant - Tonymoly Co., Ltd. (688216798) Establishment Name Address ID/FEI Business Operations Cosmax, Inc. 689049693 manufacture(59078-121)