Label: VITA WATER DROP CC- titanium dioxide, octinoxate, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 76214-048-01 - Packager: SKINFOOD 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 November 3, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive ingredient:
WATER, CYCLOPENTASILOXANE, CAPRYLYL METHICONE, METHYL TRIMETHICONE, GLYCERIN, PEG-10 DIMETHICONE, PHENYL TRIMETHICONE, ARBUTIN, DIPROPYLENE GLYCOL, TALC, DISTEARDIMONIUM HECTORITE, SODIUM CHLORIDE, BETAINE, CAPRYLYL GLYCOL, PYRUS MALUS (APPLE) FRUIT EXTRACT, DAUCUS CAROTA SATIVA (CARROT) ROOT EXTRACT, SOLANUM LYCOPERSICUM (TOMATO) FRUIT EXTRACT, CUCURBITA PEPO (PUMPKIN) FRUIT EXTRACT, BRASSICA OLERACEA ITALICA (BROCCOLI) EXTRACT, BRASSICA OLERACEA CAPITATA (CABBAGE) LEAF EXTRACT, ASPARAGUS OFFICINALIS STEM EXTRACT, APIUM GRAVEOLENS (CELERY) EXTRACT, EUTERPE OLERACEA FRUIT EXTRACT, RUBUS IDAEUS (RASPBERRY) FRUIT EXTRACT, FRAGARIA CHILOENSIS (STRAWBERRY) FRUIT EXTRACT, VACCINIUM MACROCARPON (CRANBERRY) FRUIT EXTRACT, POLYGLYCERYL-6 POLYRICINOLEATE, DIMETHICONE, METHICONE, DIMETHICONE CROSSPOLYMER, SILICA SILYLATE, ASCORBYL TETRAISOPALMITATE, DIMETHICONE/METHICONE COPOLYMER, ARACHIS HYPOGAEA (PEANUT) OIL, RETINYL PALMITATE, ADENOSINE, TRIMETHYLSILOXYSILICATE, TRIETHOXYCAPRYLYLSILANE, TOCOPHERYL ACETATE, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE, IRON OXIDES (CI 77492), IRON OXIDES (CI 77491), IRON OXIDES (CI 77499) - PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- USE
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DIRECTIONS
DIRECTIONS:
Apply liberally 15 minutes before sun exposure.
Reapply at least every 2 hours. Sun Protection Measures.
Spending time in the sun increases your risk of skin cancer and early skin aging.
To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m.
Wear long-sleeved shirts, pants, hats, and sunglasses.
Children under 6 months of age: Ask a doctor. - Other information
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VITA WATER DROP CC
titanium dioxide, octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76214-048 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.15 g in 30 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.1 g in 30 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 0.29 g in 30 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76214-048-01 30 g in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 10/01/2014 Labeler - SKINFOOD CO., LTD. (690324173) Registrant - SKINFOOD CO., LTD. (690324173) Establishment Name Address ID/FEI Business Operations SKINFOOD CO., LTD. 690324173 manufacture(76214-048)
