UV DEFENSE FACE MINERAL SPF 50- zinc oxide lotion

UV DEFENSE FACE MINERAL SPF 50 by

Drug Labeling and Warnings

UV DEFENSE FACE MINERAL SPF 50 by is a Otc medication manufactured, distributed, or labeled by BETTER INVENTION LTD, COSMAX, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Zinc oxide 17.88%

PURPOSE

Purpose

Sunscreen

USES

Uses

• help 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.

DIRECTIONS

Directions

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• 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 thi 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-sleeve shirts, pants, hats, and sunglasses.
• children under 6 months: Ask a doctor

INACTIVE INGREDIENT

Inactive ingredients

water, butyloctyl salicylate, propylheptyl caprylate, butylene glycol, isododecane, C9-12 alkane, cetyl diglyceryl tris(trimethylsiloxy)silylethyl dimethicone, caprylyl methicone, disiloxane, triethylhexanoin, glycerin, methyl methacrylate crosspolymer, disteardimonium hectorite, sodium chloride, triethoxycaprylylsilane, polymethylsilsesquioxane, 1,2-hexanediol, dipentaerythrityl tri-polyhydroxystearate, lauryl polyglyceryl-3 polydimethylsiloxyethyl dimethicone, lauryl dimethicone/polyglycerin-3 crosspolymer, magnesium sulfate, tocopherol, caprylyl glycol, glyceryl caprylate, oryza sativa (rice) bran extract, sodium ascorbyl phosphate, dipropylene glycol, sodium hyaluronate, sodium citrate, panthenol, centella asiatica extract, pentylene glycol, octanediol.

OTHER INFORMATION

Other information

• protect the product in this container from excessive heat and direct sun.

QUESTIONS or COMMENTS?

Questions or comments?

customerservice@mistineus.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UV DEFENSE FACE MINERAL SPF 50 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87458-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	17.88 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ORYZA SATIVA (RICE) BRAN (UNII: R60QEP13IC)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
CETYL DIGLYCERYL TRIS(TRIMETHYLSILOXY)SILYLETHYL DIMETHICONE (950 MM2/S) (UNII: C982F2EKT3)
LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: H49Q67JS3B)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)
C9-12 ALKANE (UNII: 7J5R5W72QM)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)
DISILOXANE (UNII: D7M4659BPU)
DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE (UNII: D21K655H52)
MAGNESIUM SULFATE (UNII: DE08037SAB)
CAPRYLYL METHICONE (UNII: Q95M2P1KJL)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TOCOPHEROL (UNII: R0ZB2556P8)
PANTHENOL (UNII: WV9CM0O67Z)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
OCTANEDIOL (UNII: 806K32R50Z)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87458-003-01	1 in 1 CARTON	02/25/2026
1		40 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 Drug	M020	02/25/2026

Labeler - BETTER INVENTION LTD (141262018)

Establishment
Name	Address	ID/FEI	Business Operations
COSMAX, INC		689049693	manufacture(87458-003)