IPKN MOIST AND FIRM BB 05 MEDIUM TAN- titanium dioxide, octinoxate, octisalate, zinc oxide 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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43526-121_Deactivation

Titanium Dioxide 10.05%

Octinoxate 7.00%

Octisalate 4.70%

Zinc Oxide 3.48%

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
GLYCERIN
IRON OXIDES(CI77492)
PEG-10 DIMETHICONE
DIPROPYLENE GLYCOL
HEXYL LAURATE
ISOEICOSANE
NIACINAMIDE
CYCLOMETHICONE
TALC
DISTEARDIMONIUM HECTORITE
IRON OXIDES(CI77491)
MAGNESIUM SULFATE
IRON OXIDES(CI77499)
C12-14 PARETH-3
ACRYLATES/DIMETHICONE COPOLYMER
PHENOXYETHANOL
METHICONE
ALUMINUM HYDROXIDE
ALUMINUM STEARATE
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER
PALMITIC ACID
TRIETHOXYCAPRYLYLSILANE
BETAINE
ETHYLHEXYLGLYCERIN
FRAGRANCE
TOCOPHERYL ACETATE
DIMETHICONE
ADENOSINE
AMINOPROPYL DIMETHICONE
POLYMETHYLSILSESQUIOXANE
CERAMIDE 3
COLLAGEN
GOLD
BUTYLENE GLYCOL
ONSEN-SUI
PRUNUS SERRULATA FLOWER EXTRACT
RICE FERMENT FILTRATE (SAKE)
MENTHYL PCA
ETHYL MENTHANE CARBOXAMIDE

image description

IPKN MOIST AND FIRM BB 05 MEDIUM TAN 
titanium dioxide, octinoxate, octisalate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43526-121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.2 mg  in 40 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2.8 mg  in 40 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.88 mg  in 40 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.52 mg  in 40 mL
Inactive Ingredients
Ingredient NameStrength
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ADENOSINE (UNII: K72T3FS567)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
CERAMIDE NP (UNII: 4370DF050B)  
GOLD (UNII: 79Y1949PYO)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PRUNUS SERRULATA FLOWER (UNII: 60I4615G0K)  
MENTHYL PYRROLIDONE CARBOXYLATE, (-),DL- (UNII: 8P18J856U2)  
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
ISOEICOSANE (UNII: AR294KAG3T)  
NIACINAMIDE (UNII: 25X51I8RD4)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
TALC (UNII: 7SEV7J4R1U)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
C12-14 PARETH-3 (UNII: 93RY22U87E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
PALMITIC ACID (UNII: 2V16EO95H1)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
BETAINE (UNII: 3SCV180C9W)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43526-121-021 in 1 CARTON01/31/201812/06/2021
1NDC:43526-121-0140 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
Kolmar Korea Co., Ltd.689512611manufacture(43526-121)

Revised: 12/2021
Document Id: d2823d44-1de8-5ddd-e053-2995a90a9d07
Set id: c43ed01e-a62f-42e5-a5f8-b6cb122950fd
Version: 4
Effective Time: 20211206
 
Inel Cosmetics Co., Ltd.