IPKN MOIST AND FIRM BB 04 MEDIUM- 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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43526-109_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

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

Water

Cyclomethicone 5

Glycerin

Talc

Peg-10 dimethicone (600 cst)

Ferric oxide yellow

dipropylene glycol

hexyl laurate

isoeicosane

niacinamide

cyclomethicone

distearlydimonium

magnesium sulfate

ferric oxide red

c12 - 14 Pareth-3

phenoxyethanol

methicone (20 cst)

Aluminum hydroxide

aluminum stearate

palmitic acid

ferrosoferric oxide

betaine

ethylhexylglycerin

.alpha.-tocopherol acetate

treithoxycaprylylsilane

dimethicone

adenosine

polymethylsilsesquiopxane (4.5 microns)

ceramide 3

gold

butylene glycol

prunus serrulata flower

ethyl methane carboxamide

image description

IPKN MOIST AND FIRM BB 04 MEDIUM 
titanium dioxide, octinoxate, octisalate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43526-109
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.02 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 OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.392 mg  in 40 mL
Inactive Ingredients
Ingredient NameStrength
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)  
DISTEARYLDIMONIUM (UNII: 251IW5I21C)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
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)  
PALMITIC ACID (UNII: 2V16EO95H1)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
BETAINE (UNII: 3SCV180C9W)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ADENOSINE (UNII: K72T3FS567)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
CERAMIDE 3 (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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43526-109-021 in 1 CARTON01/30/201812/21/2022
1NDC:43526-109-0140 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 finalpart35201/30/201812/21/2022
Labeler - Inel Cosmetics Co., Ltd. (688038939)
Registrant - Inel Cosmetics Co., Ltd. (688038939)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co., Ltd.689512611manufacture(43526-109)

Revised: 12/2022
Document Id: f0577241-0e49-3942-e053-2a95a90afda7
Set id: d42a0c8c-4a74-4b27-b076-bd9de6ac0601
Version: 6
Effective Time: 20221221
 
Inel Cosmetics Co., Ltd.