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NDC 71597-0011-02 ACWELL SOLAR DEFENSE LICORICE Suncream 7.5; 4.5; 2.2; 15.2 g/100mL; g/100mL; g/100mL; g/100mL Details
ACWELL SOLAR DEFENSE LICORICE Suncream 7.5; 4.5; 2.2; 15.2 g/100mL; g/100mL; g/100mL; g/100mL
ACWELL SOLAR DEFENSE LICORICE Suncream is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by BNHCOSMETICS CO., LTD.. The primary component is HOMOSALATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE.
Product Information
NDC | 71597-0011 |
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Product ID | 71597-011_eab2579f-a56b-284b-e053-2a95a90ac585 |
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 Suncream |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Zinc Oxide, Titanium Dioxide |
Product Type | HUMAN OTC DRUG |
Dosage Form | CREAM |
Route | TOPICAL |
Active Ingredient Strength | 7.5; 4.5; 2.2; 15.2 |
Active Ingredient Units | g/100mL; g/100mL; g/100mL; g/100mL |
Substance Name | HOMOSALATE; OCTISALATE; 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 71597-0011-02 (71597001102)
NDC Package Code | 71597-011-02 |
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Billing NDC | 71597001102 |
Package | 1 TUBE in 1 CARTON (71597-011-02) / 50 mL in 1 TUBE (71597-011-01) |
Marketing Start Date | 2022-10-10 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 422ebb58-fd31-4967-ad3e-514575ddc878 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
WATER, CYCLOPENTASILOXANE, HOMOSALATE, PROPANEDIOL, ETHYLHEXYL SALICYLATE, BUTYLOCTYL SALICYLATE, LAURYL PEG-10 TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE, NIACINAMIDE, CAPRYLYL METHICONE, VERONICA OFFICINALIS EXTRACT, POTERIUM OFFICINALE ROOT EXTRACT, PINUS SYLVESTRIS BUD EXTRACT, GLYCYRRHIZA URALENSIS (LICORICE) ROOT EXTRACT, NELUMBIUM SPECIOSUM FLOWER EXTRACT, SOLIDAGO VIRGAUREA (GOLDENROD) EXTRACT, EUGENIA CARYOPHYLLUS (CLOVE) BUD EXTRACT, ARTEMISIA VULGARIS OIL, SODIUM HYALURONATE, GLYCYRRHIZA GLABRA (LICORICE) ROOT WATER, CALCIUM ALUMINUM BOROSILICATE, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, DIMETHICONE, 1,2-HEXANEDIOL, POLYMETHYLSILSESQUIOXANE, TRIETHOXYCAPRYLYLSILANE, STEARIC ACID, ALUMINUM HYDROXIDE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, BUTYLENE GLYCOL, GLYCERYL CAPRYLATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, ADENOSINE, DIPROPYLENE GLYCOL, SODIUM CITRATE, TOCOPHEROL, SILICA, C12-15 ALKYL BENZOATE, CERIUM OXIDE, HYDROGEN DIMETHICONE, POLYHYDROXYSTEARIC ACID)
INGREDIENTS AND APPEARANCE
ACWELL SOLAR DEFENSE LICORICE SUNCREAM
zinc oxide, titanium dioxide cream |
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Labeler - BNHCOSMETICS CO., LTD. (688404819) |
Registrant - BNHCOSMETICS CO., LTD. (688404819) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Kolmar Korea Co.,LTD. Gwanjeong Factory | 689512611 | manufacture(71597-011) |