FDA.reportPublic FDA data

Photo Plasma

Manufacturer
Dimensional Merchandising Inc.
Effective date
2014-03-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:38:37

Label at a glance#

ProductPhoto Plasma
Active ingredientTITANIUM DIOXIDE
Label structure11 sections

Indications and 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

Dosage and administration

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 ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium dioxide 4.2%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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 

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Photo Plasma packagePhoto Plasma package

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61383-201-152020-01-31C16284748780-19d75b9d0-cd96-f424-e053-dadaa90a57cePhoto Plasma
61383-201-302020-01-31C16284748780-19d75b9d0-cd96-f424-e053-dadaa90a57cePhoto Plasma
61383-201-592020-01-31C16284748780-19d75b9d0-cd96-f424-e053-dadaa90a57cePhoto Plasma

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61383-201-15Photo Plasma15 mL in 1 JARCream152
61383-201-15Photo Plasma1 in 1 CARTONCream12
61383-201-30Photo Plasma1 in 1 CARTONCream12
61383-201-30Photo Plasma30 mL in 1 JARCream302
61383-201-59Photo Plasma59 mL in 1 JARCream592
61383-201-59Photo Plasma1 in 1 CARTONCream12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61383-201PHOTO PLASMA (TITANIUM DIOXIDE) CREAM [DIMENSIONAL MERCHANDISING INC.]2Legacy NDC, 6 package rows20140306_30f008d6-0173-4cc7-9321-879cbebcbdc4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP2
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP2
.ALPHA.-LIPOIC ACIDINACTIVE INGREDIENT73Y7P0K73Y2
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN02
ASTAXANTHININACTIVE INGREDIENT8XPW32PR7I2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH2
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R2
DIETHYLHEXYL SYRINGYLIDENEMALONATEINACTIVE INGREDIENT3V5U97P2482
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O2
ETHYLHEXYL METHOXYCRYLENEINACTIVE INGREDIENTS3KFG6Q5X82
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
HYDROGENATED SOYBEAN LECITHININACTIVE INGREDIENTH1109Z9J4N2
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)INACTIVE INGREDIENT86FQE96TZ42
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1E2
LEVOMENOLINACTIVE INGREDIENT24WE03BX2T2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U2
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZG2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)INACTIVE INGREDIENTT9296U138P2
POLYGLYCERYL-3 LAURATEINACTIVE INGREDIENTY9ZSR39D0E2
POLYSILICONE-15INACTIVE INGREDIENTF8DRP5BB292
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4M2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ42
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2
TETRAHEXYLDECYL ASCORBATEINACTIVE INGREDIENT9LBV3F07AZ2
WATERINACTIVE INGREDIENT059QF0KO0R2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61383-20161383-201-59, 61383-201-30, 61383-201-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
ASTAXANTHIN8XPW32PR7IIACT
BENZYL ALCOHOLLKG8494WBHIACT
LEVOMENOL24WE03BX2TIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
DIMETHICONE92RU3N3Y1OIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
GLYCERINPDC6A3C0OXIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
ISOHEXADECANE918X1OUF1EIACT
PENTYLENE GLYCOL50C1307PZGIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
POLYGLYCERYL-3 LAURATEY9ZSR39D0EIACT
POLYSILICONE-15F8DRP5BB29IACT
POLYSORBATE 60CAL22UVI4MIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
STEARIC ACID4ELV7Z65APIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
.ALPHA.-LIPOIC ACID73Y7P0K73YIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 282 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USPRAY / TOPICAL540 mgExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUENEMA / RECTAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / TOPICAL2 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER, FOR SUSPENSION / ORAL3390 mg/5mlExact identifier — unii candidate
18 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION/ DROPS / ORAL22 mgExact identifier — unii candidate
29 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SUSPENSION / INTRAMUSCULAR40 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHTABLET / ORAL1.06 mgExact identifier — unii candidate
50 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCAPSULE, EXTENDED RELEASE / ORAL64 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION, SOLUTION / INTRAMUSCULAR4.8 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEELOZENGE / ORAL1264 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SOLUTION / RECTAL6.67 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APEMULSION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.6 %w/wExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
35 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / TOPICAL185 mgExact identifier — unii candidate
50 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCAPSULE / ORAL8.5 mgExact identifier — unii candidate
35 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / ENDOTRACHEAL54 mgExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / RECTAL124 mgExact identifier — unii candidate
50 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MGUM, CHEWING / BUCCAL5 mgExact identifier — unii candidate
13 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUPPOSITORY / RECTAL129 mgExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CAPSULE / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
HYDROGENATED SOYBEAN LECITHINHYDROGENATED SOYBEAN LECITHINH1109Z9J4NINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS213 mgExact identifier — unii candidate
4 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / ORAL100 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / SOFT TISSUE23 mgExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, DELAYED RELEASE / ORAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APPOWDER, FOR SUSPENSION / ORAL1203 mg/5mlExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii candidate
26 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUELIXIR / ORAL5.02 mg/5mlExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APPELLET / SUBCUTANEOUS0.97 mgExact identifier — unii candidate
26 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CREAM / TOPICAL0.25 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, FILM COATED / ORAL1 mgExact identifier — unii candidate
35 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
26 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, EXTENDED RELEASE / ORAL528 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, EXTENDED RELEASE / ORAL7 mgExact identifier — unii candidate
75 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, FILM COATED, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii candidate
19 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii candidate
3 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE, DENTIFRICE / DENTAL0.5 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APIMPLANT / SUBCUTANEOUS1.04 mgExact identifier — unii candidate
26 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii candidate
3 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, EMULSION / INTRAMUSCULAR225 mgExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii candidate
35 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d2af787c-c2f5-40bd-bfdc-cd3dc5aa484630f008d6-0173-4cc7-9321-879cbebcbdc42014-03-06WarningsExact identifier
spl id: d2af787c-c2f5-40bd-bfdc-cd3dc5aa4846
spl set id: 30f008d6-0173-4cc7-9321-879cbebcbdc4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.