FDA.reportPublic FDA data

PRISMA PROTECT SPF30

Manufacturer
Dermalogica, LLC. | Cosway | McKenna
Effective date
2024-12-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:49:58

Label at a glance#

ProductPRISMA PROTECT SPF30
Active ingredientHomosalate, Octocrylene, Octisalate, Avobenzone
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 (10.0%)
Octisalate (5.0%)
Octocrylene (10.0%)

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, Butylene Glycol, Silica, C12-15 Alkyl Benzoate, Dimethicone, Glycerin, Butyloctyl Salicylate, Polyglyceryl-2 Distearate, VP/Eicosene Copolymer, Chlorella Vulgaris Extract, Zingiber Officinale (Ginger) Root Oil, Camellia Sinensis Leaf Extract, Tocopheryl acetate, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Arachidyl Alcohol, Dimethicone Crosspolymer, Behenyl Alcohol, Caprylic/Capric Triglyceride, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arachidyl Glucoside, Ethylhexylglycerin, Trisodium Ethylenediamine Disuccinate, Citric Acid, Sodium Citrate, Caprylyl Glycol, Polyvinyl Alcohol, 1,2-Hexanediol, Pentylene Glycol, Propanediol, Saccharide Isomerate, Bisabolol, Sodium Hydroxide, Potassium Sorbate, Sodium Benzoate, Lactic Acid/Glycolic Acid Copolymer, Heptapeptide-15 Palmitate, Limonene.

Questions or comments?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

prisma
protect

dermalogica

SPF
30

UVA
UVB

broad spectrum

moisturizer +
SPF 30

1.7 US FL OZ / 50 mL ℮

Principal Display Panel - 50 mL Tube Carton
Principal Display Panel - 50 mL Tube Carton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68479-851-01PRISMA PROTECT SPF301 in 1 CARTONLOTION12
68479-851-01PRISMA PROTECT SPF3012 mL in 1 TUBELOTION122
68479-851-02PRISMA PROTECT SPF301 in 1 CARTONLOTION12
68479-851-02PRISMA PROTECT SPF3050 mL in 1 TUBELOTION502
68479-851-04PRISMA PROTECT SPF30117 mL in 1 TUBELOTION1172

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68479-851PRISMA PROTECT SPF30 (HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONE) LOTION [DERMALOGICA, LLC.]2Current NDC, Legacy NDC, 5 package rows20250101_713bad2e-bf32-4cd5-9630-b8d88d437686.zip

Products#

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

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68479-85168479-851-02, 68479-851-01, 68479-851-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
HomosalateV06SV4M95SACTIB
Octocrylene5A68WGF6WMACTIB
Octisalate4X49Y0596WACTIB
AvobenzoneG63QQF2NOXACTIB
Water059QF0KO0RIACT
Butylene Glycol3XUS85K0RAIACT
Silicon DioxideETJ7Z6XBU4IACT
Alkyl (C12-15) BenzoateA9EJ3J61HQIACT
Dimethicone92RU3N3Y1OIACT
GlycerinPDC6A3C0OXIACT
Butyloctyl Salicylate2EH13UN8D3IACT
Polyglyceryl-2 Distearate1XAX7BOH4WIACT
Vinylpyrrolidone/Eicosene Copolymer035MV9S1C3IACT
Potassium Cetyl Phosphate03KCY6P7UTIACT
Glyceryl Monostearate230OU9XXE4IACT
PEG-100 StearateYD01N1999RIACT
Pentylene Glycol50C1307PZGIACT
Propanediol5965N8W85TIACT
Arachidyl Alcohol1QR1QRA9BUIACT
Saccharide IsomerateW8K377W98IIACT
Docosanol9G1OE216XYIACT
Caprylyl Glycol00YIU5438UIACT
Medium-Chain TriglyceridesC9H2L21V7UIACT
Xanthan GumTTV12P4NEEIACT
Levomenol24WE03BX2TIACT
Arachidyl Glucoside6JVW35JOOJIACT
Ethylhexylglycerin147D247K3PIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
Trisodium Ethylenediamine DisuccinateYA22H34H9QIACT
Ginger OilSAS9Z1SVUKIACT
Sodium Hydroxide55X04QC32IIACT
Green Tea LeafW2ZU1RY8B0IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
1,2-HexanediolTR046Y3K1GIACT
Sodium Citrate, Unspecified Form1Q73Q2JULRIACT
Potassium Sorbate1VPU26JZZ4IACT
Sodium BenzoateOJ245FE5EUIACT
Chlorella VulgarisRYQ4R60M02IACT
Polyvinyl Alcohol, Unspecified532B59J990IACT
Limonene, (+)-GFD7C86Q1WIACT

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
PRISMA PROTECT SPF30HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEDermalogica, LLC.713bad2e-bf32-4cd5-9630-b8d88d4376862024-12-30WarningsExact identifier
ndc (package): 68479-851-02
ndc (package): 68479-851-01
ndc (package): 68479-851-04
ndc (product): 68479-851
ndc11 (package): 68479085101
ndc11 (package): 68479085104
ndc11 (package): 68479085102
spl id: 506cf07b-5aef-4f3b-bdf1-91d11d4cefcf
spl set id: 713bad2e-bf32-4cd5-9630-b8d88d437686

Reported adverse events (FAERS/openFDA)#

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