VITA WATER DROP CC- titanium dioxide, octinoxate, zinc oxide cream

VITA WATER DROP CC by

Drug Labeling and Warnings

VITA WATER DROP CC by is a Otc medication manufactured, distributed, or labeled by SKINFOOD CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient: TITANIUM DIOXIDE 7.188%, ETHYLHEXYL METHOXYCINNAMATE 7.00%, ZINC OXIDE 0.985%

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

PURPOSE: Sunscreen

WARNINGS

Warning:
Skin Cancer/Skin Aging Alert
Spending time in the sun increases your risk of skin cancer and early skin aging.
This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

USE

USE:
Helps prevent sunburn.
If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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

Other information:
Protect the product in this container from excessive heat and direct sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VITA WATER DROP CC 
titanium dioxide, octinoxate, zinc oxide cream

Product 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)