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NDC 71597-0012-02 ACWELL SOLAR DEFENSE LICORICE C BLEMISH Sunstick 4.46; 22.63 g/100g; g/100g Details
ACWELL SOLAR DEFENSE LICORICE C BLEMISH Sunstick 4.46; 22.63 g/100g; g/100g
ACWELL SOLAR DEFENSE LICORICE C BLEMISH Sunstick is a TOPICAL STICK in the HUMAN OTC DRUG category. It is labeled and distributed by BNHCOSMETICS CO., LTD.. The primary component is TITANIUM DIOXIDE; ZINC OXIDE.
Product Information
| NDC | 71597-0012 |
|---|---|
| Product ID | 71597-012_eab588b1-6f42-5620-e053-2a95a90a9352 |
| 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 | ACWELL SOLAR DEFENSE LICORICE C BLEMISH Sunstick |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Zinc Oxide, Titanium Dioxide |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | STICK |
| Route | TOPICAL |
| Active Ingredient Strength | 4.46; 22.63 |
| Active Ingredient Units | g/100g; g/100g |
| Substance Name | TITANIUM DIOXIDE; ZINC OXIDE |
| Labeler Name | BNHCOSMETICS CO., LTD. |
| Pharmaceutical Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part352 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 71597-0012-02 (71597001202)
| NDC Package Code | 71597-012-02 |
|---|---|
| Billing NDC | 71597001202 |
| Package | 1 CONTAINER in 1 CARTON (71597-012-02) / 4.5 g in 1 CONTAINER (71597-012-01) |
| Marketing Start Date | 2022-10-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 5e24b0cb-9f47-43d3-950d-3df5f54f9f20 Details
SPL UNCLASSIFIED SECTION
- Apply liberally 15 minutes before sun exposure. Reapply at least every two hours
- 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 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
- Ask a doctor to use for children under 6 months
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Diphenylsiloxy Phenyl Trimethicone, Coco-Caprylate/Caprate, Butyloctyl Salicylate, Polyphenylsilsesquioxane, Mica (CI 77019), Octyldodecanol, Synthetic Wax, Diglyceryl Sebacate/Isopalmitate, Paraffin, Tridecyl Trimellitate, Polyhydroxystearic Acid, Silica, Caprylic/Capric Triglyceride, Methyl Methacrylate Crosspolymer, Triethoxycaprylylsilane, Glycyrrhiza Glabra (Licorice) Root Extract, Spirulina Maxima Extract, Poterium Officinale Root Extract, Veronica Officinalis Extract, Euphorbia Cerifera (Candelilla) Wax, Polyglyceryl-2 Triisostearate, Microcrystalline Wax, Lecithin, Ethylhexyl Palmitate, Isopropyl Myristate, Isostearic Acid, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Polyglyceryl-3 Polyricinoleate, Caprylyl Glycol, Glyceryl Caprylate, Diisostearyl Malate, Water, Ascorbic Acid, Ascorbic Acid Polypeptide, Sucrose, Butylene Glycol, 1,2-Hexanediol, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)
INGREDIENTS AND APPEARANCE
| ACWELL SOLAR DEFENSE LICORICE C BLEMISH SUNSTICK
zinc oxide, titanium dioxide stick |
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| Labeler - BNHCOSMETICS CO., LTD. (688404819) |
| Registrant - BNHCOSMETICS CO., LTD. (688404819) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Cosmax, Inc. | 689049693 | manufacture(71597-012) | |