FDA.reportPublic FDA data

Standard Procedure SPF 50 Sunscreen

Manufacturer
Standard Procedure Inc
Effective date
2026-01-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:33:01

Label at a glance#

ProductStandard Procedure SPF 50 Sunscreen
Active ingredientOCTOCRYLENE, AVOBENZONE, HOMOSALATE, OCTISALATE
Label structure9 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply generously and evenly 15 minutes before sun exposure Reapply at least every 80 minutes Usa a water resistant sunscreen if swimming or sweating Sun Protection Measures. Speading time in the sun increases your risk of skin cancer and early skin aging. To decres this risk, regularly usa a sunscreen with broad spectum SPF of 15 or higher and other sun protection measures including: Limit time in thee sun, especi...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 10%

Octocrylene 8%

Octisalate 5%

Avobenzone 3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

  • For external use only
  • Do not use on damaged orbroken skin
  • Stop use and ask a doctor if rash occurs
  • When using this product keep out of eyes
  • Rinse with water to remove

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply generously and evenly 15 minutes before sun exposure
  • Reapply at least every 80 minutes
  • Usa a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures.
    Speading time in the sun increases your risk of skin cancer and early skin aging. To decres this risk, regularly usa a sunscreen with broad spectum SPF of 15 or higher and other sun protection measures including:
    Limit time in thee sun, especially from 10 a.m. - 2 p.m, wear long-sleeve shirts, pants, hats and sunglasses, children under 6 months: Ask a doctor

Other Information

OTHER SAFETY INFORMATION

Protect the product in this container from exessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

BEESWAX, CYCLOPENTASILOXANE, CETEARYL ALCOHOL, ISOPROPYL PALMITATE, CYCLOHEXASILOXANE, CETEARETH-20, ALOE BARBADENSIS LEAF JUICE, ANANAS SATIVUS (PINEAPPLE) FRUIT EXTRACT, BENZYL ALCOHOL, CARBOMER, CARICA PAPAYA (PAPAYA) FRUIT EXTRACT, CITRIC ACID, GLYCERIN, HYDROXYACETOPHENONE, MALTODEXTRIN, MANGIFERA INDICA (MANGO) FRUIT EXTRACT, SODIUM STEAROYL GLUTAMATE, TOCOPHERYL ACETATE, TRIETHANOLAMINE, PHENOXYETHANOL, WATER

Contact

OTC - QUESTIONS SECTION

Standard Procedure Inc

2801 Ocean Park Blvd Unit #2062

Santa Monica CA 90405 USA

usa@standardprocedure.co

+1 213-681-1801

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Standard Procedure.

SPF 50+ Sunscreen

Australian Made

Broad Spectrum UVA/UVB Rays

80 minutes Water Resistant

Standard Procedure SPF 50+ SunscreenStandard Procedure SPF 50+ Sunscreen

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-139358579000091GTIN-13: 9358579000091
EAN-13: 9358579000091
GTIN storage (14 digits): 09358579000091		SP SPF50 240627.jpg
QR code linkQR Codestandardprocedure.co/pages/dynamic-qr-codes-generator?r=ZQRLAS0GMCOHSP SPF50 240627.jpg

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84425-101-01Standard Procedure SPF 50 Sunscreen60 mL in 1 BOTTLE, PLASTICLOTION602
84425-101-03Standard Procedure SPF 50 Sunscreen250 mL in 1 BOTTLE, PLASTICLOTION2502
84425-101-04Standard Procedure SPF 50 Sunscreen500 mL in 1 BOTTLE, PLASTICLOTION5002

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84425-10184425-101-01, 84425-101-03, 84425-101-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
MALTODEXTRIN7CVR7L4A2DIACT
OCTOCRYLENE5A68WGF6WMACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
AVOBENZONEG63QQF2NOXACTIB
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
PEG-8 BEESWAX3C1QUF1TIRIACT
HOMOSALATEV06SV4M95SACTIB
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
OCTISALATE4X49Y0596WACTIB
ISOPROPYL PALMITATE8CRQ2TH63MIACT
GLYCERINPDC6A3C0OXIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CYCLOMETHICONE 6XHK3U310BAIACT
ALOE VERA LEAFZY81Z83H0XIACT
CYCLOMETHICONE 50THT5PCI0RIACT
BENZYL ALCOHOLLKG8494WBHIACT
MANGOI629I3NR86IACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
PAPAYAKU94FIY6JBIACT

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
Standard Procedure SPF 50 SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEStandard Procedure Inc1d3f87de-90c0-75c0-e063-6394a90a2ef42026-01-14WarningsExact identifier
ndc (package): 84425-101-01
ndc (package): 84425-101-04
ndc (package): 84425-101-03
ndc (product): 84425-101
ndc11 (package): 84425010104
ndc11 (package): 84425010103
ndc11 (package): 84425010101
spl id: 4862fbef-e8ad-cc4b-e063-6394a90a35f2
spl set id: 1d3f87de-90c0-75c0-e063-6394a90a2ef4

Reported adverse events (FAERS/openFDA)#

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