BIRCH JUICE MOISTURIZING UVLOCK SUNSTICK SPF 50 BROAD SPECTRUM- homosalate, octocrylene, octisalate, avobenzone stick

Birch Juice Moisturizing UVLOCK Sunstick SPF 50 Broad Spectrum by

Drug Labeling and Warnings

Birch Juice Moisturizing UVLOCK Sunstick SPF 50 Broad Spectrum by is a Otc medication manufactured, distributed, or labeled by SEORIN COMPANY Co., Ltd., COSMAX, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Homosalate 9.5%

Octocrylene 5%

Octisalate 4.5%

Avobenzone 3%

Purpose

Sunscreen

Uses

- helps prevent sunburn

- if used as directed with other sun protection measures (see - Directions) decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

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 use and ask a doctor if rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

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

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

• reapply at least every 2 hours.
• apply liberally 15 minutes before sun exposure.
• 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 value of 15 or higher and other sun protection measures including:
limit time in the sun, especially from 10 a.m. - 2 p.m.
wear long-sleeved shirts, pants, hats, and sunglasses.

• children under 6 months of age: Ask a doctor

Other information

protect the product from excessive heat and direct sun

Inactive ingredients

Diethylhexyl Carbonate, Dimethicone, Methyl Methacrylate Crosspolymer, Synthetic Wax, Diphenylsiloxy Phenyl Trimethicone, Butyloctyl Salicylate, Butyl Methoxydibenzoy/methane, Isopropyl Palmitate, Phenethyl Benzoate, Diisostearyl Malate, Ethylhexyl Isononanoate, Capryty Trimethicone, Synthetic Fluorphlogopite, Bis-Behenyl/Isostearyl/Phytosteryl Dimer Dilinoleyl Dimer Dilinoleate, Polymethylsilsesquioxane, Polyethylene, Dimethicone/ Vinyl Dimethicone Crosspolymer, Camellia Japonica Seed Oil, Ethylene/Propylene Copolymer, Silica Dimethyl Silylate, Dimethicone Crosspolymer, Candelilla Wax Esters, Artemisia Annua Extract, Copemicia Cerifera (Camauba) Wax, Pinus Sylvestris Leaf Oil, Anthemis Nobilis Flower Oil, Water, Dipotassium Glycyrrhizate, Allantoin, Glyceryl Glucoside, Butylene Glycol, Glycerin, 1,2-Hexanediol, Betula Platyphylla Japonica Juice, Ulmus Davidiana Root Extract, Aloe Barbadensis Leaf Extract, Dioscorea Japonica Root Extract, Viola Mandshurica Flower Extract, Laminaria Japonica Extract, Glyceryl Caprylate, Sodium Hyaluronate, Hyaluronic Acid, Ascorbic Acid

Questions or comments?

cs@roundlab.com

PRINCIPAL DISPLAY PANEL

BIRCH JUICE MOISTURIZING

UVLOCK SUN STICK

SUN STICK

SPF50+ Broad Spectrum

ROUND LAB

19g 0.67 oz.

INGREDIENTS AND APPEARANCE

BIRCH JUICE MOISTURIZING UVLOCK SUNSTICK SPF 50 BROAD SPECTRUM 
homosalate, octocrylene, octisalate, avobenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84616-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9.5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)
DIMETHICONE (UNII: 92RU3N3Y1O)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
PHENETHYL BENZOATE (UNII: 0C143929GK)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)
CAPRYLYL TRIMETHICONE (UNII: H6HK6E4EB1)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
BIS-BEHENYL/ISOSTEARYL/PHYTOSTERYL DIMER DILINOLEYL DIMER DILINOLEATE (UNII: G27BTQ95MJ)
POLYMETHYLSILSESQUIOXANE (UNII: 59Z907ZB69)
POLYETHYLENE (UNII: UG00KM4WR7)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
ARTEMISIA ANNUA LEAF (UNII: E4M09UY5BL)
CARNAUBA WAX (UNII: R12CBM0EIZ)
ANTHEMIS NOBILIS FLOWER OIL (UNII: UB27587839)
WATER (UNII: 059QF0KO0R)
DIPOTASSIUM GLYCYRRHIZATE (UNII: CA2Y0FE3FX)
ALLANTOIN (UNII: 344S277G0Z)
GLYCERYL GLUCOSIDE (UNII: 3297VXM8Z6)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
BETULA PLATYPHYLLA JAPONICA JUICE (UNII: 1B33PG6N4K)
ULMUS DAVIDIANA ROOT (UNII: URQ79U8261)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
VIOLA MANDSHURICA FLOWER (UNII: 46MR945M6X)
LAMINARIA JAPONICA (UNII: WE98HW412B)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
HYALURONIC ACID (UNII: S270N0TRQY)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CANDELILLA WAX (UNII: WL0328HX19)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
PINUS SYLVESTRIS LEAF OIL (UNII: 5EXL5H740Y)
DIOSCOREA JAPONICA ROOT (UNII: I43FCF3356)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84616-003-01	19 g in 1 CONTAINER; Type 0: Not a Combination Product	11/06/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/06/2024

Labeler - SEORIN COMPANY Co., Ltd. (694988081)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX, INC.		689049693	manufacture(84616-003)