Label: JUNGSAEMMOOL SKIN SETTING TONE-UP SUN BASE- octinoxate, homosalate, octisalate, titanium dioxide, octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71261-018-01, 71261-018-02 - Packager: Jungsaemmool Beauty Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated February 18, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
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
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
JUNGSAEMMOOL SKIN SETTING TONE-UP SUN BASE
octinoxate, homosalate, octisalate, titanium dioxide, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71261-018 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 34 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 50 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 65 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 45 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) 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:71261-018-02 1 in 1 CARTON 02/18/2021 1 NDC:71261-018-01 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 02/18/2021 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(71261-018)
