71597-012_ACWELL SOLAR DEFENSE LICORICE C BLEMISH SUNSTICK

ACWELL SOLAR DEFENSE LICORICE C BLEMISH Sunstick by

Drug Labeling and Warnings

ACWELL SOLAR DEFENSE LICORICE C BLEMISH Sunstick by is a Otc medication manufactured, distributed, or labeled by BNHCOSMETICS CO., LTD., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACWELL SOLAR DEFENSE LICORICE C BLEMISH SUNSTICK- zinc oxide, titanium dioxide stick 
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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71597-012_ACWELL SOLAR DEFENSE LICORICE C BLEMISH SUNSTICK

Zinc Oxide 22.63%

Titanium Dioxide 4.46%

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.

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)

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

ACWELL SOLAR DEFENSE LICORICE C BLEMISH SUNSTICK 
zinc oxide, titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71597-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.46 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	22.63 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MICA (UNII: V8A1AW0880)
SYNTHETIC WAX (1800 MW) (UNII: 248P1AUJ90)
OCTYLDODECANOL (UNII: 461N1O614Y)
DIGLYCERYL SEBACATE/ISOPALMITATE (UNII: XK79T95N8Z)
PARAFFIN (UNII: I9O0E3H2ZE)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CANDELILLA WAX (UNII: WL0328HX19)
POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISOSTEARIC ACID (UNII: X33R8U0062)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
WATER (UNII: 059QF0KO0R)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
SUCROSE (UNII: C151H8M554)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ARTHROSPIRA MAXIMA (UNII: 9K7IG15M0Q)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)
VERONICA OFFICINALIS WHOLE (UNII: 9EHR580PSP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71597-012-02	1 in 1 CARTON	10/10/2022	05/03/2023
1	NDC: 71597-012-01	4.5 g in 1 CONTAINER; 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
Cosmax, Inc.		689049693	manufacture(71597-012)

Revised: 5/2023

Document Id: face1079-4376-45aa-e053-6394a90ad179

34390-5

Set id: 5e24b0cb-9f47-43d3-950d-3df5f54f9f20

Version: 2

Effective Time: 20230503