FDA.reportPublic FDA data

Prisma Protect SPF 30

Manufacturer
Dermalogica, Inc. | Cosway
Effective date
2019-03-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:53

Label at a glance#

ProductPrisma Protect SPF 30
Active ingredientAvobenzone, Homosalate, Octisalate, Octocrylene
Label structure10 sections

Indications and uses

helps prevent sunburn if used as directed with other sun care measures, (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

Apply liberally 30 minutes before sun exposure Reapply at least every two hours 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 help decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and take other sun protection measures including: - Limit time in the sun, esp...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone (3.0%)
Homosalate (10.00%)
Octisalate (5.00%)
Octocrylene (10.00%)

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun care measures, (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

OTC - STOP USE SECTION

  • if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 30 minutes before sun exposure
  • Reapply at least every two hours
  • 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 help decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and take other sun protection measures including:
    • Limit time in the sun, especially from 10 a.m. – 2 p.m.
    • Wear long-sleeve shirts, pants, hats and sunglasses
  • Do not use on infants under 6 months old

Other information

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Silica, Butylene Glycol, Coconut Alkanes, Dimethicone, Glycerin, Dimethyl Capramide, Polyglyceryl-2 Stearate, VP/Eicosene Copolymer, Chlorella Vulgaris Extract, Palmitoyl Oligopeptide, Saccharide Isomerate, Zingiber Officinale (Ginger) Root Oil, Sclareolide, Tocopherol, Camellia Sinensis Leaf Extract, Tocopheryl Acetate, Coco-Caprylate/Caprate, Glyceryl Stearate SE, PEG-100 Stearate, Potassium Cetyl Phosphate, Arachidyl Alcohol, Dimethicone Crosspolymer, Behenyl Alcohol, Benzyl Alcohol, Caprylic/Capric Triglyceride, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arachidyl Glucoside, Ethylhexylglycerin, Methicone, Sodium Hydroxide, Trisodium Ethylenediamine Disuccinate, Citric Acid, Sodium Citrate, Caprylyl Glycol, Propanediol, Polyvinyl Alcohol, Sodium Benzoate, Potassium Sorbate, 1,2-Hexanediol, Phenoxyethanol.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-831-5150 in the US.

PRINCIPAL DISPLAY PANEL - 12 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

prisma
protect

SPF
30
broad spectrum

dermalogica

light-activated skin defense

0.4 US FL OZ / 12 mL ℮

PRINCIPAL DISPLAY PANEL - 12 mL Tube Carton
PRINCIPAL DISPLAY PANEL - 12 mL Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68479-805-002021-01-29C16284748780-1ba0f9c33-0cfa-a910-e053-dadaa90a0b85Prisma Protect SPF 30
68479-805-012021-01-29C16284748780-1ba0f9c33-0cfa-a910-e053-dadaa90a0b85Prisma Protect SPF 30
68479-805-022021-01-29C16284748780-1ba0f9c33-0cfa-a910-e053-dadaa90a0b85Prisma Protect SPF 30
68479-805-042021-01-29C16284748780-1ba0f9c33-0cfa-a910-e053-dadaa90a0b85Prisma Protect SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68479-805-00Prisma Protect SPF 302 mL in 1 POUCHLOTION21
68479-805-01Prisma Protect SPF 3012 mL in 1 TUBELOTION121
68479-805-02Prisma Protect SPF 3050 mL in 1 TUBELOTION501
68479-805-04Prisma Protect SPF 30177 mL in 1 TUBELOTION1771
68479-805-04Prisma Protect SPF 301 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68479-805PRISMA PROTECT SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [DERMALOGICA, INC.]1Legacy NDC, 5 package rows20190717_b7f11dee-7824-43eb-8488-2fa453fd80bc.zip

Products#

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

DailyMed product names page 1 of 2 · 48 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68479-80568479-805-04, 68479-805-02, 68479-805-01, 68479-805-00

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 46 matching rows.

Name, UNII, Kind table
NameUNIIKind
AvobenzoneG63QQF2NOXACTIB
HomosalateV06SV4M95SACTIB
Octisalate4X49Y0596WACTIB
Octocrylene5A68WGF6WMACTIB
Water059QF0KO0RIACT
Butylene Glycol3XUS85K0RAIACT
Silicon DioxideETJ7Z6XBU4IACT
Coconut Alkanes1E5KJY107TIACT
Dimethicone92RU3N3Y1OIACT
GlycerinPDC6A3C0OXIACT
Dimethyl CapramideO29Y6X2JEZIACT
Polyglyceryl-2 Stearate253MC0P0YVIACT
Vinylpyrrolidone/Eicosene Copolymer035MV9S1C3IACT
Chlorella VulgarisRYQ4R60M02IACT
Grapefruit OilYR377U58W9IACT
Saccharide IsomerateW8K377W98IIACT
Ginger OilSAS9Z1SVUKIACT
Sclareolide37W4O0O6E6IACT
TocopherolR0ZB2556P8IACT
Green Tea LeafW2ZU1RY8B0IACT
.Alpha.-Tocopherol Acetate9E8X80D2L0IACT
Coco-Caprylate/Caprate8D9H4QU99HIACT
Glyceryl Stearate SEFCZ5MH785IIACT
PEG-100 StearateYD01N1999RIACT
Potassium Cetyl Phosphate03KCY6P7UTIACT
Arachidyl Alcohol1QR1QRA9BUIACT
Dimethicone Crosspolymer (450000 MPA.S at 12% in Cyclopentasiloxane)UF7620L1W6IACT
Docosanol9G1OE216XYIACT
Benzyl AlcoholLKG8494WBHIACT
Medium-chain TriglyceridesC9H2L21V7UIACT
Xanthan GumTTV12P4NEEIACT
Ethyl Acrylate/Methacrylic Acid/Steareth-20 Methacrylate CopolymerEPA1872R1NIACT
Arachidyl Glucoside6JVW35JOOJIACT
Ethylhexylglycerin147D247K3PIACT
Methicone (20 CST)6777U11MKTIACT
Sodium Hydroxide55X04QC32IIACT
Trisodium Ethylenediamine DisuccinateYA22H34H9QIACT
Citric Acid Monohydrate2968PHW8QPIACT
Sodium Citrate, Unspecified Form1Q73Q2JULRIACT
Caprylyl Glycol00YIU5438UIACT

Source Document#

Source XML

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
0ed0dcf8-9133-41e5-9e5b-2a68957b7467b7f11dee-7824-43eb-8488-2fa453fd80bc2019-03-07WarningsExact identifier
spl id: 0ed0dcf8-9133-41e5-9e5b-2a68957b7467
spl set id: b7f11dee-7824-43eb-8488-2fa453fd80bc

Reported adverse events (FAERS/openFDA)#

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