TONYMOLY MY SUNNY WATERPROOF SUN BLOCK- zinc oxide cream

TONYMOLY My Sunny Waterproof Sun Block by

Drug Labeling and Warnings

TONYMOLY My Sunny Waterproof Sun Block by is a Otc medication manufactured, distributed, or labeled by Tonymoly Co., Ltd., Kolmar. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Dipropylene Glycol 4.00%, Glycerin 2.00%, Titanium Dioxide 3.51%, Zinc Oxide 13.44%

Purpose

Sunscreen SPF50++

Use

This perfect sun block uses a strong UV protection system that is resistant against water, sweat, and sebum secretion. It is gentle on skin and protects the skin from harmful external factors when exposed to the outdoors.

Caution

For external use only. Avoid contact with eyes. Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear.

Keep out of reach of children

Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear.

Directions

During the last step of basic skin care, dispense an appropriate amount and evenly apply to any skin that will be exposed to ultraviolet sunlight.

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

Principal Display Panel

INGREDIENTS AND APPEARANCE

TONYMOLY MY SUNNY WATERPROOF SUN BLOCK 
suntan gels, creams, and liquids cream

Product 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)