TONYMOLY MY SUNNY BODY AND FAMILY SUN CREAM- ethylhexyl methoxycinnamate cream

TONYMOLY My Sunny Body and Family Sun Cream by

Drug Labeling and Warnings

TONYMOLY My Sunny Body and Family Sun Cream by is a Otc medication manufactured, distributed, or labeled by Tonymoly Co., Ltd., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Dimethicone 2.10%, Dipropylene Glycol 2.00%, Ethylhexyl Methoxycinnamate 7.50%, Glycerin 5.00%, Titanium Dioxide 2.90%, Zinc Oxide 4.90%

Purpose

Sunscreen

Use

This sun cream protects the skin effectively and continuously from strong ultraviolet sunlight. It has a highly-effective waterproof function so it cannot be easily washed off by water, sweat, or sebum, thereby maintaining its effect for many hours. It can be used on the face and body.

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.

Directions

Take an appropriate amount, evenly apply to face and body anywhere to be exposed to UV rays. Use as the last step of basic skin care.

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

Principal Display Panel

INGREDIENTS AND APPEARANCE

TONYMOLY MY SUNNY BODY AND FAMILY SUN CREAM 
other skin care preparations cream

Product 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)