DR.G DAILY SAFE BB SPF30 PA 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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51621-050 Dr.G Daily Safe BB SPF30 PA Plus Plus

Active Ingredient(s)

Titanium Dioxide 9.4%

Zinc Oxide 0.9%

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, Diphenylsiloxy Phenyl Trimethicone, Cyclopentasiloxane, Butylene Glycol, Ethylhexyl Methoxycinnamate, Cyclohexasiloxane, Hydrogenated Polyisobutene, Niacinamide, Cetyl PEG/PPG-10/1 Dimethicone, Caprylyl Methicone, Hexyl Laurate, Methyl Methacrylate Crosspolymer, Disteardimonium Hectorite, Sorbitan Isostearate, Pentylene Glycol, PEG-10 Dimethicone, Trimethylsiloxyphenyl Dimethicone, Tribehenin, Magnesium Sulfate, Polymethylsilsesquioxane, Iron Oxides, Dimethicone/Vinyl Dimethicone Crosspolymer, Phenoxyethanol, VP/Hexadecene Copolymer, Ceresin, Diphenyl Dimethicone, Triethoxycaprylylsilane, Iron Oxides, Aluminum Hydroxide, Stearic Acid, Fragrance(Parfum)

Package Label. Principal Dispaly Panel

DR.G DAILY SAFE BB SPF30 PA PLUS PLUS 
titanium dioxide and zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51621-050
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE9.4 mg  in 100 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.9 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51621-050-021 in 1 CARTON11/15/201403/21/2018
1NDC:51621-050-0145 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(51621-050)

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