71597-011_ACWELL SOLAR DEFENSE LICORICE SUNCREAM

ACWELL SOLAR DEFENSE LICORICE Suncream by

Drug Labeling and Warnings

ACWELL SOLAR DEFENSE LICORICE Suncream by is a Otc medication manufactured, distributed, or labeled by BNHCOSMETICS CO., LTD., Kolmar Korea Co.,LTD. Gwanjeong Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACWELL SOLAR DEFENSE LICORICE SUNCREAM- zinc oxide, titanium dioxide cream 
BNHCOSMETICS 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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71597-011_ACWELL SOLAR DEFENSE LICORICE SUNCREAM

Zinc Oxide 15.20%

Homosalate 7.5%

Octisalate 4.5%

Titanium Dioxide 2.2%

Sunscreen

- 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

Helps prevent sunburn

For external use only

Do not use on damaged or broken skin

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

Stop using and ask a doctor if rash occurs.

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

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)

Protect the product in the container from excessive heat and direct sun

ACWELL SOLAR DEFENSE LICORICE SUNCREAM 
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71597-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.2 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	15.2 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PROPANEDIOL (UNII: 5965N8W85T)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
NIACINAMIDE (UNII: 25X51I8RD4)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CALCIUM ALUMINUM BOROSILICATE (UNII: 3JRB8A35M0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
DIMETHICONE (UNII: 92RU3N3Y1O)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ARTEMISIA VULGARIS TOP OIL (UNII: 72Q967Y48V)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ADENOSINE (UNII: K72T3FS567)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)
VERONICA OFFICINALIS FLOWERING TOP (UNII: 9IH82J936J)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
TOCOPHEROL (UNII: R0ZB2556P8)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CERIC OXIDE (UNII: 619G5K328Y)
HYDROGEN DIMETHICONE (30 CST) (UNII: JF2ZJ6R2WD)
PINUS SYLVESTRIS LEAFY TWIG (UNII: Q1RGP4UB73)
NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV)
GLYCYRRHIZA URALENSIS ROOT (UNII: 42B5YD8F0K)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CLOVE (UNII: K48IKT5321)
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71597-011-02	1 in 1 CARTON	10/10/2022	05/03/2023
1	NDC: 71597-011-01	50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	10/10/2022	05/03/2023

Labeler - BNHCOSMETICS CO., LTD. (688404819)

Registrant - BNHCOSMETICS CO., LTD. (688404819)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory		689512611	manufacture(71597-011)

Revised: 5/2023

Document Id: facdf884-099e-f6a9-e053-6394a90ab7da

34390-5

Set id: 422ebb58-fd31-4967-ad3e-514575ddc878

Version: 2

Effective Time: 20230503