ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUN CUSHION- zinc oxide sponge

Round Lab Birch Juice Moisturizing UVLOCK Sun Cushion by

Drug Labeling and Warnings

Round Lab Birch Juice Moisturizing UVLOCK Sun Cushion 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

Zinc Oxide 22%

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.

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 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

Water, Butyloctyl Salicylate, Caprytyl Methicone, Methyl Trimethicone, Ethylhexyl Isononanoate, Butylene Glycol Dicaprylate/Dicaprate, Pro-panecio, Polyglypery -4 Disostearate/Polyhydroxystearate/Sebacate, Ethylhexyl Methoxycrylene, Alcohol Denat., Methyl Methacrylate Cross-polymer, Polyglycery -6 Polyricinoleate, Triethoxycaprylyisilane, Magnesium Sulfate, 1,2- Hexanediol, Distearimonium Hectorite, Polyglyceryl-6 Polyhydroxystearate, Hydroxy-acetophenone, Artemisia Annua Extract, Polyglyperin-6, Pinus Sylvestris Leaf Oil, Anthemis Nobils Flower Oil, Dipotassium Glycyrrhizate, Allantoin, Glyceryl Glucaside, Butyiene Glycol Glycerin, Tocopherol, Ascorbyl Palmitate, Betula Platyphylla Japonica Juice, Umus 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 CUSHION

SUN CUSHION

SPF50+ Broad spectrum

ROUND LAB

15g 0.52 oz.

INGREDIENTS AND APPEARANCE

ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUN CUSHION 
zinc oxide sponge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84616-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	22.28325 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HYALURONIC ACID (UNII: S270N0TRQY)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAPRYLYL METHICONE (UNII: Q95M2P1KJL)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
LAMINARIA JAPONICA (UNII: WE98HW412B)
ANTHEMIS NOBILIS FLOWER OIL (UNII: UB27587839)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BETULA PLATYPHYLLA JAPONICA JUICE (UNII: 1B33PG6N4K)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
PINUS SYLVESTRIS LEAF OIL (UNII: 5EXL5H740Y)
MAGNESIUM SULFATE (UNII: DE08037SAB)
DIPOTASSIUM GLYCYRRHIZATE (UNII: CA2Y0FE3FX)
ARTEMISIA ANNUA WHOLE (UNII: 58296FW9ZD)
PROPANEDIOL (UNII: 5965N8W85T)
WATER (UNII: 059QF0KO0R)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYGLYCERIN-6 (UNII: M51422LRAM)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERYL GLUCOSIDE (UNII: 3297VXM8Z6)
DIOSCOREA JAPONICA ROOT (UNII: I43FCF3356)
VIOLA MANDSHURICA FLOWER (UNII: 46MR945M6X)
TOCOPHEROL (UNII: R0ZB2556P8)
ULMUS DAVIDIANA ROOT (UNII: URQ79U8261)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
ARTEMISIA ANNUA LEAF (UNII: E4M09UY5BL)
ALLANTOIN (UNII: 344S277G0Z)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84616-004-01	15 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(84616-004)