ROUND LAB BIRCH JUICE MILD-UP UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM- zinc oxide cream

Round Lab Birch Juice Mild-Up UVLOCK Sunscreen SPF50 Broad Spectrum by

Drug Labeling and Warnings

Round Lab Birch Juice Mild-Up UVLOCK Sunscreen SPF50 Broad Spectrum by is a Otc medication manufactured, distributed, or labeled by SEORIN COMPANY Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Zinc Oxide 17%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

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

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.

DOSAGE & ADMINISTRATION

Directions

• apply liberally and evenly 15 minutes before sun exposure.
• 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
• reapply at least every 2 hours.
• use a water-resistant sunscreen if swimming or sweating

SPL UNCLASSIFIED SECTION

Other Information

• protect the product from excessive heat and direct sun

INACTIVE INGREDIENT

Inactive ingredients

Water, Cyclohexasiloxane, Butyloctyl Salicylate, Propanediol, Propylheptyl Caprylate, Isododecane, Caprylyl Methicone, Polyglycery-3 Polydimethylsiloxyethyl Dimethicone, Methyl Methacrylate Crosspolymer, Methyl Trimethicone, Disteardimonium Hectorite, Magnesium Sulfate, Triethoxycaprylysilane, 1,2-Hexanediol, Polyglyceryl-2 Dipolyhydroxystearate, Polymethylsilsesquioxane, Lauryl Polyglyceryl-3 Polydimethyisiloxyethyl Dimethicone, Butylene Glycol, Betula Platyphylla Japonica Juice, Glyceryl Caprylate, Caprylyl Glycol, Ethylhexy glycerin, Artemisia Ánnua Extract, Anthemis Nobilis Flower Oil, Sodium Hyaluronate, Pinus Sylvestris Leaf Oil, Glycerin, Nelumbo Nucifera Leaf Extract, Cryptomeria Japonica Leaf Extract, Saccharomyces Ferment Filtrate, Tocopherol, Glyceryl Glucoside, Hyaluronic Acid, Ascorbic Acid

QUESTIONS

Questions or comments?

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PRINCIPAL DISPLAY PANEL

BIRCH JUICE

MILD-UP UVLOCK

SUNSCREEN

SPF50+ Broad spectrum

ROUND LAB

50nL 1.69fl. oz.

INGREDIENTS AND APPEARANCE

ROUND LAB BIRCH JUICE MILD-UP UVLOCK SUNSCREEN SPF50 BROAD SPECTRUM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84616-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	17 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
ARTEMISIA ANNUA LEAF (UNII: E4M09UY5BL)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CRYPTOMERIA JAPONICA LEAF (UNII: SCM4971GZQ)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
WATER (UNII: 059QF0KO0R)
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
ISODODECANE (UNII: A8289P68Y2)
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
BETULA PLATYPHYLLA VAR. JAPONICA RESIN (UNII: 1B33PG6N4K)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
NELUMBO NUCIFERA LEAF (UNII: 60C608DPVT)
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
TOCOPHEROL (UNII: R0ZB2556P8)
PROPANEDIOL (UNII: 5965N8W85T)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL GLUCOSIDE (UNII: 3297VXM8Z6)
HYALURONIC ACID (UNII: S270N0TRQY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84616-002-01	50 mL in 1 TUBE; Type 0: Not a Combination Product	08/13/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/13/2024

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