COLOR CORRECTING PRIMER PURPLE- octinoxate, zinc oxide, titanium dioxide 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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43526-123_Deactivation

Ethylhexyl Methoxycinnamate 5%
Zinc Oxide 4.9%
Titanium Dioxide 4.15%

Sunscreen

For sunscreen use:

- Apply liberally 15 minutes before sun exposure

- Reapply at least every two hours

- Use a water resistant sunscreen if swimming or sweating

If rash or irritation occurs, stop use and ask a doctor.

When using this product, keep out of eyes. Rinse with water to remove.

Water
Cyclopentasiloxane
Diphenylsiloxy Phenyl Trimethicone
Glycerin
Butylene Glycol Dicaprylate/Dicaprate
Cyclohexasiloxane
Butylene Glycol
Niacinamide
Cetyl PEG/PPG-10/1 Dimethicone
Pentylene Glycol
Sorbitan Isostearate
Hexyldecyl Myristoyl Methylaminopropionate
Hexyl Laurate
Disteardimonium Hectorite
Magnesium Sulfate
Ultramarines (CI 77007)
Methyl Methacrylate Crosspolymer
Tribehenin
Dimethicone
PEG-10 Dimethicone
Phenoxyethanol
Glyceryl Tribehenate/Isostearate/Eicosandioate
Aluminum Hydroxide
Stearic Acid
Dimethiconol
Fragrance(Parfum)
Dimethicone Crosspolymer
Triethoxycaprylylsilane
Ethylhexylglycerin
Adenosine
Disodium EDTA
Acacia Senegal Gum
Rosa Damascena Flower Oil
Rosa Gallica Flower Extract
Hydrolyzed Rhizobian Gum
Ascorbyl Tetraisopalmitate
Sodium PCA
Urea
Trehalose
Gold (CI 77480)
Polyquaternium-51
Hexylene Glycol
Caprylyl Glycol
Triacetin
Sodium Hyaluronate

image description

COLOR CORRECTING PRIMER PURPLE 
octinoxate, zinc oxide, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43526-123
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 mg  in 40 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.96 mg  in 40 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.66 mg  in 40 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
NIACINAMIDE (UNII: 25X51I8RD4)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
HEXYLDECYL MYRISTOYL METHYLAMINOPROPIONATE (UNII: 1959TW0O9A)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERYL TRIBEHENATE/ISOSTEARATE/EICOSANDIOATE (UNII: 3Y9NJ5Z7E5)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ADENOSINE (UNII: K72T3FS567)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ACACIA (UNII: 5C5403N26O)  
ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
ROSA GALLICA FLOWER (UNII: X8W61WUV70)  
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
UREA (UNII: 8W8T17847W)  
TREHALOSE (UNII: B8WCK70T7I)  
GOLD (UNII: 79Y1949PYO)  
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 4:1) (UNII: X8Q92E1CPM)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIACETIN (UNII: XHX3C3X673)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43526-123-021 in 1 CARTON01/31/201812/06/2021
1NDC:43526-123-0140 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/31/201812/06/2021
Labeler - Inel Cosmetics Co., Ltd. (688038939)
Registrant - Inel Cosmetics Co., Ltd. (688038939)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(43526-123)

Revised: 12/2021
Document Id: d2825e43-c719-559b-e053-2a95a90a019e
Set id: 84e58d1e-047d-4ddc-8c5d-9df6d8ee42ac
Version: 4
Effective Time: 20211206
 
Inel Cosmetics Co., Ltd.