TONYMOLY MY SUNNY BODY AND FAMILY SUN CREAM- other skin care preparations cream 
Tonymoly Co., Ltd.

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.

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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

sun cream

TONYMOLY MY SUNNY BODY AND FAMILY SUN CREAM 
other skin care preparations cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN6295 mg  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE27489 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59078-121-011 in 1 CARTON01/19/2016
1100 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34601/14/2016
Labeler - Tonymoly Co., Ltd. (688216798)
Registrant - Tonymoly Co., Ltd. (688216798)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(59078-121)

Revised: 2/2016
Document Id: 2af6dab7-0e94-245f-e054-00144ff88e88
Set id: 29ddedc4-e8fc-4b41-e054-00144ff88e88
Version: 3
Effective Time: 20160204
 
Tonymoly Co., Ltd.