DR.G DEEP MOIST UP SUN- octinoxate, octisalate, homosalate, octocrylene, 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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Octinoxate 6.80%
Octisalate 4.50%
Homosalate 3.00%
Octocrylene 2.50%
Titanium Dioxide 2.10%

Sunscreen

Helps prevent sunburn

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours

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 using and ask a doctor if rash occurs.

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

WATER, BUTYLENE GLYCOL, C12-15 ALKYL BENZOATE, DIETHYLAMINO HYDROXYBENZOYL HEXYLBENZOATE, ALCOHOL, 1,2-HEXANEDIOL, NIACINAMIDE, CETYL ETHYLHEXANOATE, C20-22 ALKYL PHOSPHATE, C20-22 ALCOHOLS, CAPRYLYL METHICONE, POLYMETHYLSILSESQUIOXANE, GLYCERYL STEARATE, BEHENYL ALCOHOL, ALUMINUM STEARATE, POLYHYDROXYSTEARIC ACID, TROMETHAMINE, SODIUM ACRYLATE/ SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, PROPANEDIOL, POLYISOBUTENE, ALUMINA, POLYACRYLATE CROSSPOLYMER-6, SACCHARIDE HYDROLYSATE, ETHYLHEXYLGLYCERIN, GLYCERYL CAPRYLATE, OCTYLDODECANOL, XANTHAN GUM, CITRUS AURANTIUM BERGAMIA (BERGAMOT)FRUIT OIL, OLEA EUROPAEA (OLIVE) OIL, PELARGONIUM GRAVEOLENS FLOWER OIL, ADENOSINE, TRITICUM VULGARE (WHEAT) GERM OIL UNSAPONIFIABLES, SORBITAN OLEATE, GLYCINE SOJA (SOYBEAN) OILUNSAPONIFIABLES, CAPRYLYL/CAPRYL GLUCOSIDE, CURCUMA LONGA (TURMERIC) ROOT EXTRACT, SALVIA HISPANICA SEED EXTRACT, CENTELLA ASIATICA EXTRACT, PORTULACA OLERACEA EXTRACT, HOUTTUYNIA CORDATA EXTRACT, ECHIUM PLANTAGINEUM SEED OIL, SODIUM HYALURONATE, POLLEN EXTRACT, SALVIA OFFICINALIS (SAGE) OIL,POGOSTEMON CABLIN OIL, t-BUTYL ALCOHOL, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, HELIANTHUS ANNUUS (SUN FLOWER) SEED OIL UNSAPONIFIABLES, CERAMIDE NP, CHOLESTEROL, HYDROXYPROPYLTRIMONIUM HYALURONATE, HYDROLYZED HYALURONIC ACID, CAPRYLIC/CAPRIC TRIGLYCERIDE, TOCOPHEROL, PHOSPHOLIPIDS, GLYCINE SOJA (SOYBEAN) STEROLS, LINOLEIC ACID, BIOSACCHARIDE GUM-4, PINUS PINASTER BARK EXTRACT

image description

DR.G DEEP MOIST UP SUN
octinoxate, octisalate, homosalate, octocrylene, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51621-205
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	68 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	30 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	25 mg in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	21 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
ALCOHOL (UNII: 3K9958V90M)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
NIACINAMIDE (UNII: 25X51I8RD4)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)
C20-22 ALCOHOLS (UNII: O4M0347C6A)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DOCOSANOL (UNII: 9G1OE216XY)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
TROMETHAMINE (UNII: 023C2WHX2V)
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
PROPANEDIOL (UNII: 5965N8W85T)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
ALUMINUM OXIDE (UNII: LMI26O6933)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
INVERT SUGAR (UNII: ED959S6ACY)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
OCTYLDODECANOL (UNII: 461N1O614Y)
XANTHAN GUM (UNII: TTV12P4NEE)
BERGAMOT OIL (UNII: 39W1PKE3JI)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
ADENOSINE (UNII: K72T3FS567)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
TURMERIC (UNII: 856YO1Z64F)
CHIA SEED (UNII: NU0OLX06F8)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
PURSLANE (UNII: M6S840WXG5)
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)
ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SAGE OIL (UNII: U27K0H1H2O)
PATCHOULI OIL (UNII: F3IN55X5PO)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR)
CERAMIDE NP (UNII: 4370DF050B)
CHOLESTEROL (UNII: 97C5T2UQ7J)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TOCOPHEROL (UNII: R0ZB2556P8)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SOY STEROL (UNII: PL360EPO9J)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
MARITIME PINE (UNII: 50JZ5Z98QY)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51621-205-02	1 in 1 CARTON	12/14/2017	12/27/2017
1	NDC:51621-205-01	50 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	12/14/2017	12/27/2017

Labeler - GOWOONSESANG COSMETICS CO., LTD. (631170768)

Registrant - GOWOONSESANG COSMETICS CO., LTD. (631170768)

Name	Address	ID/FEI	Business Operations
Establishment
Kolmar Korea Co., Ltd.		689512611	manufacture(51621-205)

Revised: 12/2017

Document Id: 6ecd4f3b-26ec-45f6-88e1-c4997a664d92

Set id: ac11f36e-d005-46f0-a561-22656aa5cceb

Version: 2

Effective Time: 20171227

GOWOONSESANG COSMETICS CO., LTD.