JUNGSAEMMOOL SKIN SETTING TONE-UP SUN 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.

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71261-018_JUNGSAEMMOOL SKIN SETTING TONE-UP SUN 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, PEG-100 STEARATE, 1,2-HEXANEDIOL, METHYL METHACRYLATE CROSSPOLYMER, CETEARYL ALCOHOL, POLYGLYCERYL-2 CAPRATE, PANTHENOL, CAPRYLYL METHICONE, POLYSORBATE 60, TITANIUM DIOXIDE (CI 77891), AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, MICA, OCTYLDODECANOL, CAPRYLYL GLYCOL, SUCROSE STEARATE, SQUALANE, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, FRAGRANCE (PARFUM), STEARIC ACID, ALUMINA, GLYCERYL CAPRYLATE, XANTHAN GUM, ETHYLHEXYLGLYCERIN, POLYACRYLATE CROSSPOLYMER-6, ECHIUM PLANTAGINEUM SEED OIL, POLYACRYLATE-13, IRON OXIDES (CI 77491), HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, POLYISOBUTENE, ALUMINUM HYDROXIDE, IRON OXIDES (CI 77492), CITRONELLOL, HYDROXYCITRONELLAL, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, LIMONENE, LINALOOL, POLYSORBATE 20, SORBITAN ISOSTEARATE, ALPHA-ISOMETHYL IONONE, t-BUTYL ALCOHOL, ETHYLHEXYL PALMITATE, SODIUM PCA, TOCOPHEROL, TRIHYDROXYSTEARIN, ROSA CANINA FRUIT EXTRACT, HIPPOPHAE RHAMNOIDES FRUIT EXTRACT, SODIUM HYALURONATE, COPPER TRIPEPTIDE-1, MYRCIARIA DUBIA FRUIT EXTRACT

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

image description

JUNGSAEMMOOL SKIN SETTING TONE-UP SUN BASE 
octinoxate, homosalate, octisalate, titanium dioxide, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71261-018
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE34 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE50 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE65 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 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)  
ALCOHOL (UNII: 3K9958V90M)  
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)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SUCROSE STEARATE (UNII: 274KW0O50M)  
SQUALANE (UNII: GW89575KF9)  
JOJOBA OIL (UNII: 724GKU717M)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
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)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)  
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
PREZATIDE COPPER (UNII: 6BJQ43T1I9)  
MYRCIARIA DUBIA FRUIT (UNII: YSW4EM1EKP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71261-018-021 in 1 CARTON02/18/2021
1NDC:71261-018-0140 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 finalpart35202/18/2021
Labeler - Jungsaemmool Beauty Co., Ltd. (694214725)
Registrant - Jungsaemmool Beauty Co., Ltd. (694214725)
Establishment
NameAddressID/FEIBusiness Operations
Shinsegae Intercos Korea Inc.694526100manufacture(71261-018)

Revised: 2/2021
Document Id: bba57257-f094-acc8-e053-2995a90ac0e3
Set id: 7849f438-d712-4f4d-8910-05775467916b
Version: 1
Effective Time: 20210218
 
Jungsaemmool Beauty Co., Ltd.