Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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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 Bottle Label

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 30ml Bottle Label

Principal Display Panel - Prismatic Protectant SPF50 10ml Bottle Label

VOLITION

PRISMATIC
LUMINIZING
SHIELD

SPF50

10 ML/0.34 FL OZ

Principal Display Panel - Prismatic Protectant SPF50 10ml Bottle Label
PRISMATIC PROTECTANT SPF50 
zinc oxide, titanium dioxide, octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 72577-326
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE190 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE33 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 72577-326-101 in 1 CARTON03/01/2018
130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC: 72577-326-2010 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2018
Labeler - Volition Beauty (023668513)
Establishment
NameAddressID/FEIBusiness Operations
PhytogenX, Inc.624386772manufacture(72577-326)

Revised: 11/2019
 
Volition Beauty


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