JUNGSAEMMOOL ESSENTIAL SKIN NUDER LONGWEAR CUSHION LIGHT- titanium dioxide, octinoxate, zinc oxide, octisalate 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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71261-012_JUNGSAEMMOOL Essential Skin Nuder Longwear Cushion Light

Titanium Dioxide 9.6%
Octinoxate 7.0%
Zinc Oxide 4.9%
Octisalate 4.5%

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, Cyclopentasiloxane, Methyl Methacrylate Crosspolymer, Butylene Glycol, Methyl Trimethicone, Dimethicone, Glycerin, Niacinamide, Pentylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Silica, Caprylyl Methicone, Butylene Glycol Dicaprylate/Dicaprate, PEG/PPG-17/6 Copolymer, Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone, Iron Oxides (CI 77492), Magnesium Sulfate, Phenoxyethanol, Sorbitan Isostearate, Aluminum Hydroxide, Dimethicone/Vinyl Dimethicone Crosspolymer, Disteardimonium Hectorite, Stearic Acid, Iron Oxides (CI 77491), Triethoxycaprylylsilane, Fragrance(Parfum), Ethylhexylglycerin, Iron Oxides (CI 77499), Adenosine, Trisodium Ethylenediamine Disuccinate, Camellia Sinensis Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Ceramide NP, Helianthus Annuus (Sunflower) Seed Oil, Panthenol, Jasminum Officinale (Jasmine) Flower/Leaf Extract, Nelumbo Nucifera Flower Extract, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Tocopherol, Freesia Refracta Extract, Iris Ensata Extract, Iris Versicolor Extract, Leontopodium Alpinum Flower/Leaf Extract, Lilium Candidum Bulb Extract, Narcissus Pseudonarcissus (Daffodil) Flower Extract, Rose Extract

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

image description

JUNGSAEMMOOL ESSENTIAL SKIN NUDER LONGWEAR CUSHION LIGHT 
titanium dioxide, octinoxate, zinc oxide, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71261-012
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE96 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE70 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION49 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
PEG/PPG-17/6 COPOLYMER (UNII: P5QZM4T259)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ADENOSINE (UNII: K72T3FS567)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CAMELLIA SINENSIS SEED OIL (UNII: O5R6DK2M9K)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
CERAMIDE NP (UNII: 4370DF050B)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
PANTHENOL (UNII: WV9CM0O67Z)  
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)  
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC)  
LEONTOPODIUM NIVALE SUBSP. ALPINUM FLOWERING TOP (UNII: QQC1AK06RK)  
LILIUM CANDIDUM BULB (UNII: AHG15J8AM0)  
NARCISSUS PSEUDONARCISSUS FLOWER (UNII: L879RBF1WN)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71261-012-022 in 1 CARTON07/16/2020
1NDC:71261-012-0114 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/16/2020
Labeler - Jungsaemmool Beauty Co., Ltd. (694214725)
Registrant - Jungsaemmool Beauty Co., Ltd. (694214725)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc689049693manufacture(71261-012)

Revised: 7/2023
Document Id: 00dc6780-83f1-14cd-e063-6394a90a447b
Set id: 377cc2f7-27f2-4b2a-bbce-7b437ed520b5
Version: 2
Effective Time: 20230719
 
Jungsaemmool Beauty Co., Ltd.