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NDC 43526-0119-02 Flash Radiant Primer 2; 1.2; 1.136 mg/40mL; mg/40mL; mg/40mL Details
Flash Radiant Primer 2; 1.2; 1.136 mg/40mL; mg/40mL; mg/40mL
Flash Radiant Primer 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.
Product Information
| NDC | 43526-0119 |
|---|---|
| Product ID | 43526-119_ec11c679-83a6-4482-baef-db9a5de34c7a |
| 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 | Flash Radiant Primer |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Titanium Dioxide, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 2; 1.2; 1.136 |
| Active Ingredient Units | mg/40mL; mg/40mL; mg/40mL |
| Substance Name | OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE |
| 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 43526-0119-02 (43526011902)
| NDC Package Code | 43526-119-02 |
|---|---|
| Billing NDC | 43526011902 |
| Package | 1 CONTAINER in 1 CARTON (43526-119-02) / 40 mL in 1 CONTAINER (43526-119-01) |
| Marketing Start Date | 2018-01-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 5b5b167e-b6f9-4bdd-af4f-6d051608f702 Details
SPL UNCLASSIFIED SECTION
INSTRUCTIONS FOR USE
Apply liberally 15 minutes before sun exposure
Reapply at least every two hours
Use a water resistant sunscreen if swimming or sweating
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 or higher and other sun protection measures including:
Limit time in the sun, especially from 10a.m. - 2p.m.
Wear long-sleeve shirts, pants, hats, and sunglasses
Children under 6 months: Ask a doctor.
For external use only
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
WATER
CYCLOPENTASILOXANE
GLYCERIN
TALC
PEG-10 DIMETHICONE
DIPROPYLENE GLYCOL
HEXYL LAURATE
ISOEICOSANE
NIACINAMIDE
CYCLOMETHICONE
DISTEARDIMONIUM HECTORITE
IRON OXIDES(CI 77492)
MAGNESIUM SULFATE
DIMETHICONE
C12-14 PARETH-3
ACRYLATES/DIMETHICONE COPOLYMER
PHENOXYETHANOL
METHICONE
ALUMINUM HYDROXIDE
IRON OXIDES(CI 77491)
ALUMINUM STEARATE
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER
PALMITIC ACID
FRAGRANCE
BETAINE
ETHYLHEXYLGLYCERIN
TOCOPHERYL ACETATE
IRON OXIDES(CI 77499)
TRIETHOXYCAPRYLYLSILANE
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
INGREDIENTS AND APPEARANCE
| FLASH RADIANT PRIMER
titanium dioxide, ethylhexyl methoxycinnamate, ethylhexyl salicylate 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(43526-119) | |