Prismatic Protectant SPF50 by PhytogenX, Inc.

Prismatic Protectant SPF50 by

Drug Labeling and Warnings

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

Drug Details [pdf]

PRISMATIC PROTECTANT SPF50- zinc oxide, titanium dioxide, octinoxate lotion 
PhytogenX, Inc.

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.

----------

Principal Display Panel - Shipping Label

VOLITION BEAUTY

PRISMATIC SHEER PROTECTANT SPF 50 (OTC) 30ML

PO#:1118

ITEM#: FL-009

SKU#: 4543

BATCH#: B18248

JOB#: 18248

LOT#: B26BHA

EXP: 02/20

UNITS/CARTON: 000

7 18088 00454 3

Case: 0

PRISMATIC PROTECTANT SPF50 
zinc oxide, titanium dioxide, octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 19355-326
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: 19355-326-02	1 in 1 CARTON	03/01/2019
1		30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 19355-326-01	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	03/01/2019

Labeler - PhytogenX, Inc. (624386772)

Establishment
Name	Address	ID/FEI	Business Operations
PhytogenX, Inc.		624386772	manufacture(19355-326)

Revised: 1/2021

Document Id: ba112e58-4cf1-7199-e053-2a95a90af957

34390-5

Set id: c4733773-58bd-40fb-a8aa-68b50d80123b

Version: 4

Effective Time: 20210129