Prismatic Protectant SPF50 by Volition Beauty / PhytogenX, Inc. Drug Facts

Prismatic Protectant SPF50 by

Drug Labeling and Warnings

Prismatic Protectant SPF50 by is a Otc medication manufactured, distributed, or labeled by Volition Beauty, PhytogenX, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRISMATIC PROTECTANT SPF50- zinc oxide, titanium dioxide, octinoxate lotion 
Volition Beauty

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients

Titanium Dioxide: 3.5%

Zinc Oxide: 19.6%

Octinoxate: 7.5%

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

Cyclopentasiloxane, Water, Coconut Alkanes, Isododecane, Glycerin, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, PEG/PPG-18/18 Dimethicone, Adipic Acid/Neopentyl Glycol Crosspolymer, Lauryl Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Aluminum Hydroxide, Stearic Acid, Butylene Glycol, Phenoxyethanol, Synthetic Fluorphlogopite, Titanium Dioxide, Hydrogenated Polyisobuetene, Actinidia Chinensis (Kiwi) Fruit Water, Coco-Caprylate/Caprate, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Alcohol, Sophora Flavescens Root Extract, Sodium Hyaluronate, Glycyrrhiza Uralensis (Licorice) Root Extract, Hydrogenated Lecithin, CI 77491, CI 77492.

Principal Display Panel - Prismatic Protectant SPF50 Bottle Label

VOLITION

PRISMATIC
LUMINIZING
SHIELD

SPF50

30 ML/1.0 FL OZ

Principal Display Panel - Prismatic Protectant SPF50 30ml Bottle Label

VOLITION

PRISMATIC
LUMINIZING
SHIELD

SPF50

30 ML/1.0 FL OZ

Principal Display Panel - Prismatic Protectant SPF50 10ml Bottle Label

VOLITION

PRISMATIC
LUMINIZING
SHIELD

SPF50

10 ML/0.34 FL OZ

PRISMATIC PROTECTANT SPF50 
zinc oxide, titanium dioxide, octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72577-326
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	190 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	33 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PPG-17 (UNII: OV0Q322E0U)
CYCLOHEXANOL (UNII: 8E7S519M3P)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
ISODODECANE (UNII: A8289P68Y2)
ADIPIC ACID (UNII: 76A0JE0FKJ)
NEOPENTYL GLYCOL (UNII: QI80HXD6S5)
ISOBUTYLENE (UNII: QA2LMR467H)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
COCONUT ALKANES (UNII: 1E5KJY107T)
COCO-CAPRYLATE (UNII: 4828G836N6)
GLYCERIN (UNII: PDC6A3C0OX)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
GLYCYRRHIZA URALENSIS (UNII: 42B5YD8F0K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72577-326-10	1 in 1 CARTON	03/01/2018
1		30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 72577-326-20	10 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2018

Labeler - Volition Beauty (023668513)

Establishment
Name	Address	ID/FEI	Business Operations
PhytogenX, Inc.		624386772	manufacture(72577-326)

Revised: 11/2019

Document Id: 9857bf42-e083-076f-e053-2a95a90a5a2a

34390-5

Set id: c7bbd7b8-d5af-44e7-82ad-cefe68f74c8b

Version: 3

Effective Time: 20191127

 

Volition Beauty