IPKN Twinkle Velvet Founcushion 21 by Inel Cosmetics Co., Ltd. / Cosmax, Inc. 43526-125_Deactivation

IPKN Twinkle Velvet Founcushion 21 by

Drug Labeling and Warnings

IPKN Twinkle Velvet Founcushion 21 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 21- 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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43526-125_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
Caprylyl Methicone
Dimethicone
Iron Oxides (CI 77492)
Mica (CI 77019)
Phenoxyethanol
C30-45 Alkyl Cetearyl Dimethicone Crosspolymer
Magnesium Sulfate
PEG-10 Dimethicone
Stearic Acid
Alumina
Disteardimonium Hectorite
Iron Oxides (CI 77491)
Fragrance(Parfum)
Triethoxycaprylylsilane
Aluminum Hydroxide
Dimethicone Crosspolymer
Ethylhexylglycerin
Iron Oxides (CI 77499)
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

IPKN TWINKLE VELVET FOUNCUSHION 21 
titanium dioxide, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43526-125
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.58 g  in 12 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.8 g  in 12 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.48 g  in 12 g

Inactive Ingredients
Ingredient Name	Strength
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)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
DIMETHICONE (UNII: 92RU3N3Y1O)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MICA (UNII: V8A1AW0880)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM OXIDE (UNII: LMI26O6933)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ADENOSINE (UNII: K72T3FS567)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43526-125-02	1 in 1 CARTON	01/31/2018	12/12/2019
1	NDC: 43526-125-01	12 g 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	01/31/2018	12/12/2019

Labeler - Inel Cosmetics Co., Ltd. (688038939)

Registrant - Inel Cosmetics Co., Ltd. (688038939)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(43526-125)

Revised: 12/2019

Document Id: 9986f773-7036-df07-e053-2a95a90a956e

34390-5

Set id: 82332b92-61ca-430f-acd5-a6a472833585

Version: 4

Effective Time: 20191212

 

Inel Cosmetics Co., Ltd.