DR.G MOIST AMPLE CC CUSHION SPF50 PLUS PA PLUS PLUS PLUS LIGHT BEIGE- titanium dioxide and zinc oxide liquid 
GOWOONSESANG COSMETICS 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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51621-061 DR.G Moist Ample CC Cushion SPF50 Plus PA Plus Plus Plus Light Beige

Active ingredient(s)

Titanium Dioxide 9.8%

Zinc Oxide 7.5%

Purpose(s)

Sunscreen

Uses

  • 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 su

Warnings

For external use only

  • Do not use on damaged or broken skin
  • When using this product keep out of eyes. Rinse with water to remove
  • Stop use and ask a doctor if rash occurs
  • Keep out of reach of children

Directions

  • apply generously 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating

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

Inactive ingredients

Sea Water, Cyclopentasiloxane, Ethylhexyl Methoxycinnamate, Caprylyl Methicone, Lauryl PEG-10 Tris(trimethylsiloxy)silylethyl Dimethicone, Cyclohexasiloxane, Trimethylsiloxysilicate, Polypropylsilsesquioxane, Dipropylene Glycol, Arbutin, Hexyl Laurate, water, Methyl Hydrogenated Rosinate, Disteardimonium Hectorite, CI 77492, Sodium Chloride, Phenoxyethanol, Propylene Carbonate, Ethylhexylglycerin, Caprylyl Glycol, Fragrance, Boron Nitride, CI 77491, Dextrin, Butylene Glycol, CI 77499, Allantoin, Tropolone, Adenosine, Triethoxycaprylylsilane, CI 19140, Disodium EDTA, Aloe Barbadensis Leaf Extract, Dimethicone, Hyaluronic Acid, Butyrospermum Parkii (Shea Butter), Panax Ginseng Root Extract, Ginkgo Biloba Leaf Extract, Centella Asiatica Extract

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DR.G MOIST AMPLE CC CUSHION SPF50 PLUS PA PLUS PLUS PLUS LIGHT BEIGE 
titanium dioxide and zinc oxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51621-061
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE9.8 mg  in 100 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.5 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
ARBUTIN (UNII: C5INA23HXF)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51621-061-021 in 1 CARTON11/15/201403/23/2018
1NDC:51621-061-0113 mg in 1 CASE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/15/201403/23/2018
Labeler - GOWOONSESANG COSMETICS CO., LTD. (631170768)
Registrant - GOWOONSESANG COSMETICS CO., LTD. (631170768)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc689049693manufacture(51621-061)

Revised: 3/2018
 
GOWOONSESANG COSMETICS CO., LTD.