DR.G MEDI UV ULTRA SUN SPF 50 PLUS PA PLUS PLUS PLUS- zinc oxide and titanium dioxide cream 
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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51621-052 Dr.G Medi UV Ultra Sun SPF 50 Plus PA Plus Plus Plus

Active Ingredient(s)

Zinc Oxide 5.0%

Titanium Dioxide 4.0%

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 sun

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

Water, Cyclopentasiloxane, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Glycerin, Dicaprylyl Carbonate, Dipropylene Glycol, PEG-10 Dimethicone, Dimethicone, Niacinamide, Disteardimonium Hectorite, Portulaca Oleracea Extract, Silica, Opuntia Ficus-Indica Extract, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Centella Asiatica Extract, Houttuynia Cordata Extract, Pueraria Lobata Root Extract, Sophora Flavescens Root Extract, Cimicifuga Racemosa Root Extract, Punica Granatum Fruit Extract, Hippophae Rhamnoides Fruit Extract, Sodium Hyaluronate, Calendula Officinalis Flower Extract, Theobroma Grandiflorum Seed Butter, Thermus Thermophillus Ferment, Helianthus Annuus (Sunflower) Seed Extract, Hedera Helix (Ivy) Extract, Butyrospermum Parkii (Shea) Seedcake Extract, Magnesium Sulfate

Package Label. Principal Display Panel

DR.G MEDI UV ULTRA SUN SPF 50 PLUS PA PLUS PLUS PLUS 
zinc oxide and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51621-052
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5 mg  in 100 mg
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51621-052-021 in 1 CARTON11/15/201403/21/2018
1NDC:51621-052-0150 mg in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/15/201403/21/2018
Labeler - GOWOONSESANG COSMETICS CO., LTD. (631170768)
Registrant - GOWOONSESANG COSMETICS CO., LTD. (631170768)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co., Ltd.689512611manufacture(51621-052)

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