JUNGSAEMMOOL SKIN SETTING TONE CORRECTING BASE- octinoxate, homosalate, octisalate, titanium dioxide, octocrylene cream

JUNGSAEMMOOL Skin Setting Tone Correcting Base by

Drug Labeling and Warnings

JUNGSAEMMOOL Skin Setting Tone Correcting Base by is a Otc medication manufactured, distributed, or labeled by Jungsaemmool Beauty Co., Ltd., Shinsegae Intercos Korea Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Octinoxate 6.5%
Homosalate 5.0%
Octisalate 4.5%
Titanium Dioxide 3.4%
Octocrylene 3.0%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn

DOSAGE & ADMINISTRATION

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

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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses

Ask a doctor to use for children under 6 months

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 using and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

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

INACTIVE INGREDIENT

WATER (AQUA), BUTYLENE GLYCOL, DIBUTYL ADIPATE, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, GLYCERYL STEARATE, ALCOHOL DENAT., GLYCERIN, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, TITANIUM DIOXIDE (CI 77891), PEG-100 STEARATE, 1,2-HEXANEDIOL, METHYL METHACRYLATE CROSSPOLYMER, CETEARYL ALCOHOL, POLYGLYCERYL-2 CAPRATE, PANTHENOL, CAPRYLYL METHICONE, POLYSORBATE 60, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, MICA, OCTYLDODECANOL, CHROMIUM OXIDE GREENS (CI 77288), FRAGRANCE (PARFUM), CAPRYLYL GLYCOL, SUCROSE STEARATE, SQUALANE, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, IRON OXIDES (CI 77492), STEARIC ACID, ALUMINA, GLYCERYL CAPRYLATE, CENTELLA ASIATICA EXTRACT, POLYACRYLATE-13, XANTHAN GUM, ETHYLHEXYLGLYCERIN, POLYACRYLATE CROSSPOLYMER-6, ECHIUM PLANTAGINEUM SEED OIL, ALUMINUM HYDROXIDE, POLYISOBUTENE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, POLYSORBATE 20, SORBITAN ISOSTEARATE, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, t-BUTYL ALCOHOL, ETHYLHEXYL PALMITATE, SODIUM PCA, TOCOPHEROL, TRIHYDROXYSTEARIN, SODIUM HYALURONATE, COPPER TRIPEPTIDE-1

OTHER SAFETY INFORMATION

Protect the product in the container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JUNGSAEMMOOL SKIN SETTING TONE CORRECTING BASE 
octinoxate, homosalate, octisalate, titanium dioxide, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71261-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	65 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	34 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIBUTYL ADIPATE (UNII: F4K100DXP3)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
BEMOTRIZINOL (UNII: PWZ1720CBH)
PEG-100 STEARATE (UNII: YD01N1999R)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYGLYCERYL-2 CAPRATE (UNII: JX7WXJ41DH)
PANTHENOL (UNII: WV9CM0O67Z)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
POLYSORBATE 60 (UNII: CAL22UVI4M)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
MICA (UNII: V8A1AW0880)
OCTYLDODECANOL (UNII: 461N1O614Y)
CHROMIC OXIDE (UNII: X5Z09SU859)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SUCROSE STEARATE (UNII: 274KW0O50M)
SQUALANE (UNII: GW89575KF9)
JOJOBA OIL (UNII: 724GKU717M)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM OXIDE (UNII: LMI26O6933)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)
XANTHAN GUM (UNII: TTV12P4NEE)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PREZATIDE COPPER (UNII: 6BJQ43T1I9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71261-009-02	1 in 1 CARTON	07/14/2020
1	NDC: 71261-009-01	40 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/14/2020

Labeler - Jungsaemmool Beauty Co., Ltd. (694214725)

Registrant - Jungsaemmool Beauty Co., Ltd. (694214725)

Establishment
Name	Address	ID/FEI	Business Operations
Shinsegae Intercos Korea Inc.		694526100	manufacture(71261-009)