PHOTO PLASMA- titanium dioxide cream

Photo Plasma by

Drug Labeling and Warnings

Photo Plasma by is a Otc medication manufactured, distributed, or labeled by Dimensional Merchandising Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Titanium dioxide 4.2%

Purpose

Sunscreen

Keep out of reach of children

If swallowed, get medical help or contact a Posion Control Center right away.

Uses

• Helps prevents sun burn
• 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 extenal 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.

Directions 

• Dr.Perricone recommends applying in the day time as a final and finishing step to any skin care regimen.
• Apply liberally 15 minutes before sun exposure.
• Use a water resistant sunscreen if swimming or sweating.
• Reapply at least every 2 hours.
• Not for use on Children.
• 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 sun screen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including
• limit time in the sun especially from 10 am. - 2 pm.
• wear long sleaved shirts, Pants, hats and sun glasses

Other Information

• Protect the product from excessive heat and direct sun.
• Lot number and expiration date -see bottom of the carton

Inactive Ingredients

Aluminum Hydroxide, Astaxanthin, Benzyl alcohol, Bisabolol,Caprylic /Capric Triglyceride, Cyclopentasiloxane, Diethylhexyl Syringy lidenemalonate, Dimethicone, Ethylhexyl Methoxycrylene, Glycerin, Hydrogenated Lecithin, Hydrogenated phosphatidylcholine, Hydroxyethyl Acrylate /Sodium Acrylodimethyl Taurate copolymer, Isohexadecane, Pentylene Glycol, Phenoxyethanol, Polyester-8 ,Polyglyceryl-3 Polydimethylsibxy-ethyl Dimethicone,Polysilicone-11,Polysorbate 60, Potassium Sorbate, Sodium Benzoate, Stearic Acid, Tetrahexyldecyl Ascorbate, Thioctic Acid, Water, Xanthan Gum.

SPL UNCLASSIFIED SECTION

Questions:1 888 823 7837

SPL UNCLASSIFIED SECTION

Distributed by:NV Perricone LLC, Meriden CT 06 450,

Made in USA

Distributed by:NV Perricone MD Cosmeceuticals LTD London, WIT 3LN UK

Packaging

INGREDIENTS AND APPEARANCE

PHOTO PLASMA 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61383-201
Route of Administration	Topical

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ASTAXANTHIN (UNII: 8XPW32PR7I)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LEVOMENOL (UNII: 24WE03BX2T)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
ISOHEXADECANE (UNII: 918X1OUF1E)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
POLYGLYCERYL-3 LAURATE (UNII: Y9ZSR39D0E)
POLYSILICONE-15 (UNII: F8DRP5BB29)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARIC ACID (UNII: 4ELV7Z65AP)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-LIPOIC ACID (UNII: 73Y7P0K73Y)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	pink	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61383-201-59	1 in 1 CARTON
1		59 mL in 1 JAR
2	NDC: 61383-201-30	1 in 1 CARTON
2		30 mL in 1 JAR
3	NDC: 61383-201-15	1 in 1 CARTON
3		15 mL in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/01/2013

Labeler - Dimensional Merchandising Inc. (076693183)

Establishment
Name	Address	ID/FEI	Business Operations
Dimensional Merchandising Inc.		076693183	manufacture(61383-201)