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

----------

71261-009_JUNGSAEMMOOL Skin Setting Tone Correcting Base

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

Sunscreen

Helps prevent sunburn

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

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 (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

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

image description

JUNGSAEMMOOL SKIN SETTING TONE CORRECTING BASE 
octinoxate, homosalate, octisalate, titanium dioxide, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71261-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE65 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE34 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71261-009-021 in 1 CARTON07/14/2020
1NDC:71261-009-0140 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/14/2020
Labeler - Jungsaemmool Beauty Co., Ltd. (694214725)
Registrant - Jungsaemmool Beauty Co., Ltd. (694214725)
Establishment
NameAddressID/FEIBusiness Operations
Shinsegae Intercos Korea Inc.694526100manufacture(71261-009)

Revised: 7/2020
Document Id: aa6ed295-efea-24ae-e053-2a95a90aaa7e
Set id: 06a10357-1e6e-4f9a-b75d-9ee93cc14210
Version: 1
Effective Time: 20200714
 
Jungsaemmool Beauty Co., Ltd.