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NDC 43526-0108-02 IPKN Moist and Firm BB 03 Light Medium 2.8; 1.88; 4.02; 1.392 mg/40mL; mg/40mL; mg/40mL; mg/40mL Details
IPKN Moist and Firm BB 03 Light Medium 2.8; 1.88; 4.02; 1.392 mg/40mL; mg/40mL; mg/40mL; mg/40mL
IPKN Moist and Firm BB 03 Light Medium is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Inel Cosmetics Co., Ltd.. The primary component is OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE.
Product Information
| NDC | 43526-0108 |
|---|---|
| Product ID | 43526-108_a7f5276e-cd9d-47b2-93fc-f8d3cd69e55b |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | IPKN Moist and Firm BB 03 Light Medium |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Titanium Dioxide, Octinoxate, Octisalate, Zinc Oxide |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 2.8; 1.88; 4.02; 1.392 |
| Active Ingredient Units | mg/40mL; mg/40mL; mg/40mL; mg/40mL |
| Substance Name | OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE |
| Labeler Name | Inel Cosmetics Co., Ltd. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part352 |
| Listing Certified Through | 2022-12-31 |
Package
Package Images
NDC 43526-0108-02 (43526010802)
| NDC Package Code | 43526-108-02 |
|---|---|
| Billing NDC | 43526010802 |
| Package | 1 TUBE in 1 CARTON (43526-108-02) / 40 mL in 1 TUBE (43526-108-01) |
| Marketing Start Date | 2018-01-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 2f993b96-3fba-4ef8-b13f-424f3895bcfd Details
INSTRUCTIONS FOR USE
SPL UNCLASSIFIED SECTION
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
ehyl methane carboxamide
INGREDIENTS AND APPEARANCE
| IPKN MOIST AND FIRM BB 03 LIGHT MEDIUM
titanium dioxide, octinoxate, octisalate, zinc oxide cream |
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| Labeler - Inel Cosmetics Co., Ltd. (688038939) |
| Registrant - Inel Cosmetics Co., Ltd. (688038939) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Kolmar Korea Co., Ltd. | 689512611 | manufacture(43526-108) | |
Revised: 1/2018
Document Id: a7f5276e-cd9d-47b2-93fc-f8d3cd69e55b
Set id: 2f993b96-3fba-4ef8-b13f-424f3895bcfd
Version: 5
Effective Time: 20180130