ULTRA VIOLETTE VELVET SCREEN BLURRING MINERAL SKINSCREEN BROAD SPECTRUM SPF 40- zinc oxide cream

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

ZINC OXIDE 25%

PURPOSE

SUNSCREEN

INDICATIONS & USAGE

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

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 for Sunscreen Use

● apply liberally and evenly 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 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

Inactive Ingredients

Water, Coco-Caprylate/Caprate, Dicaprylyl Carbonate, Caprylic/ Capric Triglyceride, Silica, Copernicia Cerfera (Carnauba) Wax, Microcrystalline Cellulose, Stearalkonium Hectorite, Glycerin, Triethoxycaprylylsilane, Polyglyceryl-3 Diisostearate, Polyglyceryl-3 Polyricinoleate, Saccharide lsomerate, Polyhydroxystearic Acid, Hydroxyacetophenone, Sodium Chlorde, Phenoxyethanol, Propanediol, Panthenol, Tocopheryl Acetate, Pongamol, Oryza Sativa (Rice) Bran Wax, Citric Acid, Bisabolol,, Sodium Hydroxide, Xanthan Gum, Disodium EDTA, Glycyrrhiza Glabra (Licorice) Root Extract, Nelumbo Nucifera (Lotus) Flower Wax, Sodium Citrate, Pantolactone, Tocopherol, Ganoderma Lucidum (Mushroom) Extract, Iron Oxides (C.I. 77492), Iron Oxides (C.I. 77491),

Iron Oxides (C.I. 77499)

Other Information

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

PRINCIPAL DISPLAY PANEL

ULTRA VIOLETTE

VELVET SCREEN BROAD SPECTRUM SPF 40

BLURRING MINERAL SKINSCREEN

1.7 FL. OZ../ 50 ml

INGREDIENTS AND APPEARANCE

ULTRA VIOLETTE VELVET SCREEN BLURRING MINERAL SKINSCREEN BROAD SPECTRUM SPF 40 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84803-115
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	250 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PANTHENOL (UNII: WV9CM0O67Z)
ORYZA SATIVA (RICE) BRAN (UNII: R60QEP13IC)
EDETATE DISODIUM (UNII: 7FLD91C86K)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
COPERNICIA CERIFERA (CARNAUBA) WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
CI 77499 (UNII: XM0M87F357)
BISABOLOL (UNII: 24WE03BX2T)
NELUMBO NUCIFERA FLOWER WAX (UNII: U01S6C427I)
GLYCYRRHIZA GLABRA (LICORICE) ROOT (UNII: 2788Z9758H)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CI 77492 (UNII: EX438O2MRT)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPANEDIOL (UNII: 5965N8W85T)
CITRIC ACID (UNII: 2968PHW8QP)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
PANTOLACTONE (UNII: J288D7O0JS)
REISHI (UNII: TKD8LH0X2Z)
PONGAMOL (UNII: 8Y19QCY6I4)
CI 77491 (UNII: 1K09F3G675)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84803-115-50	50 mL in 1 TUBE; Type 0: Not a Combination Product	05/27/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/27/2026

Labeler - Grace and Fire USA Inc. (119357605)