DERMA DR.LAB DAILY MILD SUN- octinoxate, octisalate, zinc oxide, 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.

----------

51621-204 Derma Dr.lab Daily Mild Sun

Octinoxate 7.50%
Octisalate 5.00%
Zinc Oxide 4.80%
Titanium Dioxide 2.49%

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, CYCLOPENTASILOXANE, DIPROPYLENE GLYCOL, GLYCERIN, PEG-10 DIMETHICONE, DICAPRYLYL CARBONATE, MICA, DISTEARDIMONIUM HECTORITE, DIMETHICONE, MAGNESIUM SULFATE, SILICA, PHENOXYETHANOL, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, ALUMINUM HYDROXIDE, ALUMINUM STEARATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, METHICONE, GLYCERYL CAPRYLATE, CAPRYLYL GLYCOL, POLYGLYCERYL-6 POLYRICINOLEATE, FRAGRANCE, IRON OXIDES(CI 77492), TRIETHOXYCAPRYLYLSILANE, IRON OXIDES(CI 77491), IRON OXIDES(CI 77499), BUTYLENE GLYCOL, CAMELLIA JAPONICA SEED OIL, MORINGA PTERYGOSPERMA SEED OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, PROPYLENE GLYCOL, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, OPUNTIA FICUS-INDICA EXTRACT, NELUMBO NUCIFERA FLOWER EXTRACT, BELLIS PERENNIS (DAISY) FLOWER EXTRACT, SORBITOL, SODIUM HYDROXIDE, CITRIC ACID, CITRUS UNSHIU PEEL EXTRACT, MELISSA OFFICINALIS EXTRACT, PRUNUS PERSICA (PEACH) LEAF EXTRACT, ETHYLHEXYLGLYCERIN, TOCOPHEROL, POTASSIUM SORBATE

image description

DERMA DR.LAB DAILY MILD SUN
octinoxate, octisalate, zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51621-204
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	48 mg in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	24.9 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
MICA (UNII: V8A1AW0880)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
METHICONE (20 CST) (UNII: 6777U11MKT)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)
MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
OPUNTIA FICUS-INDICA (UNII: 23Z87HTQ6P)
NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)
BELLIS PERENNIS FLOWER (UNII: 26I94X9A1K)
SORBITOL (UNII: 506T60A25R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TANGERINE PEEL (UNII: JU3D414057)
MELISSA OFFICINALIS (UNII: YF70189L0N)
PRUNUS PERSICA LEAF (UNII: VN3501T41P)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TOCOPHEROL (UNII: R0ZB2556P8)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51621-204-02	1 in 1 CARTON	08/17/2017	04/05/2018
1	NDC:51621-204-01	45 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	08/17/2017	04/05/2018

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(51621-204)

Revised: 4/2018

Document Id: c66897fb-4487-4a01-9cb5-dbb63332ead1

Set id: 61a53fc5-63f3-41fb-aa73-4a89c5b9687d

Version: 2

Effective Time: 20180405

GOWOONSESANG COSMETICS CO., LTD.