FDA.reportPublic FDA data

Standard Procedure SPF 50+ Sunscreen Face and Body Lotion

Manufacturer
Baxter Laboratories
Effective date
2026-05-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:57:28

Label at a glance#

ProductStandard Procedure SPF 50 Sunscreen Face and Body
Active ingredientAVOBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

Avobenzone3%, Homosalate 10%, Octisalate 5%, Octocrylene 8% Sunscreen

OTC - PURPOSE SECTION

Purpose

Sunscreen

Uses

  • Helps prevent sunburn
  • 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

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

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs

WARNINGS SECTION

Warnings

For external use only

Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Apply generously and evenly
  • Reapply
  • after 80 minutes of swimming
  • Immediately after towel drying
  • at least every 2 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 decrease this risk, regularly use a sunscreen with broad spectrum SPF 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. to 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: ask a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Water, Beeswax, Isopropyl Palmitate, Cetearyl Alcohol, Cyclopentasiloxane, Cyclohexasiloxane, Ceteareth-20, Hydroxyacetophenone, Carbomer, Benzyl alcohol, Phenoxyethanol, Sodium Stearoyl Glutamate, Triethanolamine, Tocopheryl Acetate, Glycerin, Maltodextrin, Aloe Barbadensis Leaf Juice, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Ananas Sativus (Pineapple) Fruit Extract, Citric Acid.

OTHER SAFETY INFORMATION

Other information

  • protect the product in this container from excessive heat and direct sun

OTC - QUESTIONS SECTION

Questions?

1 213-681-1801 or usa@standardprocedure.co

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Standard Procedure

SPF 50+ sunscreen

For face and body

Broad Spectrum UVA/UVB

80 Minutes Water Resistant

Added Australian Superfruits with Antioxidants and Vitamins A, B + C

Standard Procedure SPF 50 LotionStandard Procedure SPF 50 Lotion

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-139358579000114GTIN-13: 9358579000114
EAN-13: 9358579000114
GTIN storage (14 digits): 09358579000114		Standard Procedure SPF50 (USA) 250305_500mL.jpg
QR code linkQR Codestandardprocedure.co/pages/dynamic-qr-codes-generator?r=ZQRLAS0GMCOHStandard Procedure SPF50 (USA) 250305_500mL.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
70157-027-01Standard Procedure SPF 50 Sunscreen Face and Body60 mL in 1 BOTTLE, PLASTICLOTION602
70157-027-02Standard Procedure SPF 50 Sunscreen Face and Body100 mL in 1 BOTTLE, PLASTICLOTION1002
70157-027-03Standard Procedure SPF 50 Sunscreen Face and Body250 mL in 1 BOTTLE, PLASTICLOTION2502
70157-027-04Standard Procedure SPF 50 Sunscreen Face and Body500 mL in 1 BOTTLE, PUMPLOTION5002
70157-027-05Standard Procedure SPF 50 Sunscreen Face and Body35 mL in 1 TUBELOTION352

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70157-02770157-027-01, 70157-027-02, 70157-027-03, 70157-027-04, 70157-027-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
PAPAYAKU94FIY6JBIACT
BEESWAX2ZA36H0S2VIACT
CETEARETH-20YRC528SWUYIACT
CYCLOMETHICONE 50THT5PCI0RIACT
CYCLOMETHICONE 6XHK3U310BAIACT
PHENOXYETHANOLHIE492ZZ3TIACT
AVOBENZONEG63QQF2NOXACTIB
ALOE VERA LEAF JUICERUE8E6T4NBIACT
CARBOMER0A5MM307FCIACT
MALTODEXTRIN7CVR7L4A2DIACT
CITRIC ACID2968PHW8QPIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
BENZYL ALCOHOLLKG8494WBHIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
MANGOI629I3NR86IACT
OCTISALATE4X49Y0596WACTIB
WATER059QF0KO0RIACT
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ISOPROPYL PALMITATE8CRQ2TH63MIACT
PINEAPPLE2A88ZO081OIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERINPDC6A3C0OXIACT
TRIETHANOLAMINE9O3K93S3TKIACT

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 Sunscreen Face and BodyAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBaxter Laboratories34f6150d-9627-94a5-e063-6394a90ad4482026-05-13WarningsExact identifier
ndc (package): 70157-027-02
ndc (package): 70157-027-04
ndc (package): 70157-027-03
ndc (package): 70157-027-01
ndc (package): 70157-027-05
ndc (product): 70157-027
ndc11 (package): 70157002703
ndc11 (package): 70157002705
ndc11 (package): 70157002701
ndc11 (package): 70157002702
ndc11 (package): 70157002704
spl id: 51babec8-0d7b-9842-e063-6394a90a30fb
spl set id: 34f6150d-9627-94a5-e063-6394a90ad448

Reported adverse events (FAERS/openFDA)#

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