Label: PHOTO PLASMA- titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 61383-201-15, 61383-201-30, 61383-201-59 - Packager: Dimensional Merchandising Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated March 6, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Keep out of reach of children
- Uses
- Warnings
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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
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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
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
PHOTO PLASMA
titanium dioxide creamProduct 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)