DR.G RADIANCE DUAL ESSENCE BB SPF50 PLUS PA PLUS PLUS PLUS- titanium dioxide and zinc oxide 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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51621-056 Dr.G Radiance Dual Essence BB SPF50 Plus PA Plus Plus Plus

Active ingredient(s)

Titanium Dioxide 13.8%

Zinc Oxide 3.9%

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

Centella Asiatica Leaf Water, Cyclopentasiloxane, Ethylhexyl Methoxycinnamate, Cyclohexasiloxane, Butylene Glycol, Phenyl Trimethicone, Glycerin, Niacinamide, Dicaprylyl Carbonate, Butylene Glycol Dicaprylate/Dicaprate, Cetyl PEG/PPG-10/1 Dimethicone, Methyl Methacrylate Crosspolymer, Sodium Chloride, Isoamyl p-Methoxycinnamate, Pentylene Glycol, Hydrogenated Poly(C6-14 Olefin), Sorbitan Isostearate, Disteardimonium Hectorite, Iron Oxides, Cetyl Dimethicone, Polyglyceryl-4 Isostearate, Aluminum Hydroxide, Phenoxyethanol, Stearic Acid, Trihydroxystearin, Triethoxycaprylylsilane, Fragrance(Parfum)

Package Label.Principal Display Panel

DR.G RADIANCE DUAL ESSENCE BB SPF50 PLUS PA PLUS PLUS PLUS 
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51621-056
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE13.8 mg  in 100 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.9 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51621-056-021 in 1 CARTON11/15/201403/21/2018
1NDC:51621-056-0140 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
Cosmax, Inc689049693manufacture(51621-056)

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