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TONYMOLY My Sunny Body and Family Sun Cream

Medically reviewed on February 5, 2018

Dosage form: cream
Ingredients: GLYCERIN 6295mg in 100mL, ZINC OXIDE 27489mg in 100mL
Labeler: Tonymoly Co., Ltd.
NDC Code: 59078-121

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.

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

Established Pharmacological Class
SubstancePharmacological Class
TONYMOLY My Sunny Body and Family Sun CreamOther Skin Care Preparations
TONYMOLY MY SUNNY BODY AND FAMILY SUN CREAM 
ethylhexyl methoxycinnamate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-121
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCERIN (GLYCERIN) GLYCERIN6295 mg  in 100 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE27489 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALUMINUM HYDROXIDE 
METHYLPARABEN 
GLYCERYL CAPRYLATE 
MAGNESIUM SULFATE 
CHLORPHENESIN 
CAFFEINE 
DISTEARDIMONIUM HECTORITE 
STEARIC ACID 
PROPYLPARABEN 
CYCLOMETHICONE 5 
OCTISALATE 
AMILOXATE 
BUTYLENE GLYCOL 
PORTULACA OLERACEA WHOLE 
Packaging
#Item CodePackage Description
1NDC:59078-121-011 TUBE in 1 CARTON
1100 mL in 1 TUBE
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/FEIOperations
Cosmax, Inc.689049693manufacture(59078-121)

 
Tonymoly Co., Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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