IPKN Twinkle Velvet Founcushion 23 by Inel Cosmetics Co., Ltd. / Cosmax, Inc. 43526-126_Deactivation

IPKN Twinkle Velvet Founcushion 23 by

Drug Labeling and Warnings

IPKN Twinkle Velvet Founcushion 23 by is a Otc medication manufactured, distributed, or labeled by Inel Cosmetics Co., Ltd., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

IPKN TWINKLE VELVET FOUNCUSHION 23- titanium dioxide, octinoxate, octisalate cream 
Inel Cosmetics 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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43526-126_Deactivation

TITANIUM DIOXIDE 13.20%
OCTINOXATE 6.70%
OCTISALATE 4.00%

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
Butylene Glycol
Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone
Pentylene Glycol
Butylene Glycol Dicaprylate/Dicaprate
Niacinamide
Silica
Iron Oxides (CI 77492)
Caprylyl Methicone
Dimethicone
Phenoxyethanol
C30-45 Alkyl Cetearyl Dimethicone Crosspolymer
Magnesium Sulfate
PEG-10 Dimethicone
Mica (CI 77019)
Iron Oxides (CI 77491)
Stearic Acid
Alumina
Disteardimonium Hectorite
Fragrance(Parfum)
Triethoxycaprylylsilane
Aluminum Hydroxide
Dimethicone Crosspolymer
Iron Oxides (CI 77499)
Ethylhexylglycerin
Adenosine
Hydrogenated Castor Oil Isostearate
Disodium EDTA
Glycerin
Aloe Barbadensis Leaf Extract
Nelumbo Nucifera Flower Extract
Bambusa Vulgaris Water
Caprylic/Capric Triglyceride
Sodium Hyaluronate
Acrylates/Dimethicone Copolymer
Anthemis Nobilis Flower Extract
Hydrogenated Lecithin
Dipropylene Glycol
Ceramide NP
Hamamelis Virginiana (Witch Hazel) Extract

image description

IPKN TWINKLE VELVET FOUNCUSHION 23 
titanium dioxide, octinoxate, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43526-126
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.58 g  in 12 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.8 g  in 12 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.48 g  in 12 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
NIACINAMIDE (UNII: 25X51I8RD4)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ADENOSINE (UNII: K72T3FS567)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)  
BAMBUSA VULGARIS WHOLE (UNII: WCD45M1BSK)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
CERAMIDE NP (UNII: 4370DF050B)  
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43526-126-021 in 1 CARTON01/31/201812/12/2019
1NDC: 43526-126-0112 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 finalpart35201/31/201812/12/2019
Labeler - Inel Cosmetics Co., Ltd. (688038939)
Registrant - Inel Cosmetics Co., Ltd. (688038939)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(43526-126)

Revised: 12/2019
 
Inel Cosmetics Co., Ltd.