DR. G A CLEAR OIL CONTROL SUN SPF50 PLUS PA PLUS PLUS PLUS- 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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51621-054 Dr. G A Clear Oil Control Sun SPF50 Plus PA Plus Plus Plus

Active ingredient(s)

Titanium Dioxide 4.2%

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, Butylene Glycol, Cyclohexasiloxane, Glycerin, 4-Methylbenzylidene Camphor, Butyl Methoxydibenzoylmethane, Niacinamide, Methyl Methacrylate Crosspolymer, Ethylhexyl Salicylate, Octocrylene, Glyceryl Stearate, Neopentyl Glycol Diheptanoate, Dicaprylyl Carbonate, Cetearyl Alcohol, PEG-100 Stearate, Opuntia Ficus-Indica Extract, Aloe Barbadensis Leaf Extract, Centella Asiatica Leaf Water, Chamaecyparis Obtusa Water, Magnolia Kobus Phytoplacenta Extract, Portulaca Oleracea Extract, Agrimonia Eupatoria Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Salix Nigra (Willow) Bark Extract, Nymphaea Alba Flower Extract, Calendula Officinalis Flower Extract, Hedera Helix (Ivy) Leaf/Stem Extract, Butyrospermum Parkii (Shea) Seedcake Extract, Helianthus Annuus (Sunflower) Seed Extract, Thermus Thermophillus Ferment, Gaultheria Procumbens (Wintergreen) Leaf Extract, Oxygen, Triceteareth-4 Phosphate, Glycol Stearate, Silica, Potassium Cetyl Phosphate, Sorbitan Sesquioleate, Polysorbate 60, PEG-2 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Glyceryl Caprylate, Caprylyl Glycol, Dimethicone, Adenosine

Package Label.Principal Display Panel

DR. G A CLEAR OIL CONTROL SUN SPF50 PLUS PA PLUS PLUS PLUS 
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51621-054
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.2 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51621-054-021 in 1 CARTON11/15/201401/09/2018
1NDC:51621-054-0150 mg in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/15/201401/09/2018
Labeler - GOWOONSESANG COSMETICS CO., LTD. (631170768)
Registrant - GOWOONSESANG COSMETICS CO. LTD. (631170768)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc689049693manufacture(51621-054)

Revised: 1/2018
 
GOWOONSESANG COSMETICS CO., LTD.