Mineral Prismatic Luminizing Shield SPF 35 by Volition Beauty Drug Facts

Mineral Prismatic Luminizing Shield SPF 35 by

Drug Labeling and Warnings

Mineral Prismatic Luminizing Shield SPF 35 by is a Otc medication manufactured, distributed, or labeled by Volition Beauty. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MINERAL PRISMATIC LUMINIZING SHIELD SPF 35- zinc oxide liquid 
Volition Beauty

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Drug Facts

Active Ingredient

Zinc Oxide 23.3%

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 avoid direct contact with eyes. Rinse with water to remove.

Stop using and ask a doctor if rash occurs.

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

Directions

• Shake well. Apply over entire face 30 minutes before sun exposure.
• Reapply at least every 2 hours or as needed. Can be worn alone or under makeup.
• 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. -1 p.m.
• wear long-sleeve shirts, pants, hats and sunglasses
• children under 6 months of age: Ask a doctor.

Other information

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

Inactive Ingredients

Water/Aqua/Eau, Ethylhexyl Olivate, C13-15 Alkane, Butyloctyl Salicylate, Polyglyceryl-3 Polyricinoleate, Sorbitan Isostearate, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Triethoxycaprylylsilane, Synthetic Fluorphlogopite, Glycerin, Sodium Chloride, Squalane, Butylene Glycol, Actinidia Chinensis (Kiwi) Fruit Water, Sodium Benzoate, Bisabolol, Potassium Sorbate, Alcohol, Sophora Flavescens Root Extract, Hydrolyzed Sodium Hyaluronate, Glycyrrhiza Glabra (Licorice) Root Extract, Ascorbic Acid, Sodium Ferrocyanide, Hydrogenated Lecithin, Iron Oxides (Cl 77499), Iron Oxides (Cl 77492), Iron Oxides (Cl 77491), Titanium Dioxide (Cl 77891).

Principal Display Panel - 30 mL Carton Label

VOLITION

MINERAL
PRISMATIC
LUMINIZING
SHIELD

SPF 35

30 ML / 1 FL OZ

Principal Display Panel - 30 mL Bottle Label

VOLITION

MINERAL
PRISMATIC
LUMINIZING
SHIELD

SPF 35

30 ML / 1 FL OZ

MINERAL PRISMATIC LUMINIZING SHIELD SPF 35 
zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72577-525
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Cation - UNII:13S1S8SF37)	Zinc Cation	270 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Ethylhexyl Oleate (UNII: R34927QY59)
C13-15 Alkane (UNII: 114P5I43UJ)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Polyglyceryl-3 Pentaricinoleate (UNII: 7Q0OK5DOT4)
Sorbitan Isostearate (UNII: 01S2G2C1E4)
Argan Oil (UNII: 4V59G5UW9X)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Magnesium Potassium Aluminosilicate Fluoride (UNII: YK3DC63Y5M)
Glycerin (UNII: PDC6A3C0OX)
Sodium Chloride (UNII: 451W47IQ8X)
Squalane (UNII: GW89575KF9)
Butylene Glycol (UNII: 3XUS85K0RA)
Kiwi Fruit Oil (UNII: 66086CWP3Q)
Sodium benzoate (UNII: OJ245FE5EU)
Levomenol (UNII: 24WE03BX2T)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Ferric Oxide Yellow (UNII: EX438O2MRT)
Alcohol (UNII: 3K9958V90M)
Sophora Flavescens Root (UNII: IYR6K8KQ5K)
Ferric Oxide Red (UNII: 1K09F3G675)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Glycyrrhiza Glabra (UNII: 2788Z9758H)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Hydrogenated Soybean Lecithin (UNII: H1109Z9J4N)
Ferrosoferric Oxide (UNII: XM0M87F357)
Sodium Ferrocyanide (UNII: 5HT6X21AID)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72577-525-12	1 in 1 CARTON	04/01/2021	12/31/2023
1	NDC: 72577-525-10	30 mL in 1 BOTTLE; 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	04/01/2021	12/31/2023

Labeler - Volition Beauty (023668513)

Revised: 11/2023

Document Id: 1d658b8a-5d05-4082-998e-559a0c95c12a

34390-5

Set id: 420c9bc3-4935-42d5-bf28-55a8329b0186

Version: 2

Effective Time: 20231130