FDA.reportPublic FDA data

Standard Procedure SPF 50 Sunscreen Face and Body

Product NDC
70157-027
11-digit product format
701570027
Labeler code
70157
Product ID
70157-027_51babec8-0d7b-9842-e063-6394a90a30fb
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
Baxter Laboratories
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-30
Substance
AVOBENZONE; OCTISALATE; HOMOSALATE; OCTOCRYLENE
Active strength
3; 5; 10; 8 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Standard Procedure SPF 50 Sunscreen Face and Body
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100mL
OCTISALATE5 g/100mL
HOMOSALATE10 g/100mL
OCTOCRYLENE8 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
4X49Y0596WInternal UNII lookup
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
34f6150d-9627-94a5-e063-6394a90ad448Available on FDA.report

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

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 176 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Curology The Lip Balm Broad Spectrum SPF 30 SunscreenZINC OXIDECurology Inc.e441b13f-cb58-457f-e053-2a95a90adab92025-10-15WarningsExact identifier
application number: M020
Curology Everyday Sunscreen Broad Spectrum SPF 30 No-clog UV defenseZINC OXIDECurology39a2a297-3af2-40d3-8b5d-f4eef2487fb22025-10-15WarningsExact identifier
application number: M020
Colorescience Total Protection No Show Mineral SunscreenZINC OXIDEColorescience00d8bf32-aecd-22da-e063-6294a90a75672025-10-15WarningsExact identifier
application number: M020
TOCOBO Cotton Airy Sun StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON CO., Ltd.412975d8-0b8b-23bf-e063-6294a90a55682025-10-14WarningsExact identifier
application number: M020
TOCOBO Bio Watery Sun ScreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEPICTON CO., Ltd.4129e00b-951d-adbf-e063-6294a90a675e2025-10-14WarningsExact identifier
application number: M020
Sunny Sailor First Mate Face Stick SPF 30ZINC OXIDESUNNY SAILOR LLCc7908385-ff93-4c6c-9462-081c730235712025-10-13WarningsExact identifier
application number: M020
Cloud Brush On Sunscreen SPF 50ZINC OXIDEFUTURE 8 LLC8b1eaf6c-9cd8-4c5e-beac-b8539c332ae32025-10-13WarningsExact identifier
application number: M020
Sunplus Mist Sunscreen SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESUNPLUS SKIN CARE LLC951a7bdc-d5c5-4241-a482-c30a4b44f7762025-10-13WarningsExact identifier
application number: M020
Sunplus Mist Sunscreen SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENESUNPLUS SKIN CARE LLCda338ba7-7a92-4157-97f4-5ae9cc64853c2025-10-13WarningsExact identifier
application number: M020
Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE , ZINC OXIDESkinlycious Pte Ltde0ad02c3-f5ed-4b72-ba96-07d9c489a4ea2025-10-13WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCdad4b244-2d34-40cb-88dc-991358df83b02025-10-10WarningsExact identifier
application number: M020
Neutrogena Beach Defense Kids Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLCeafc00ce-12e7-921f-e053-2995a90a241a2025-10-10WarningsExact identifier
application number: M020
Meijer SPF 50 Sunscreen MangoAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMeijer40d0294b-e937-336d-e063-6294a90a5c3c2025-10-10WarningsExact identifier
application number: M020
Vertra S Dorian Kona Gold Signature Face Stick SPF 38TITANIUM DIOXIDEEai-jr 286, Incb6c316c3-661b-6428-e053-2a95a90a1a6b2025-10-10WarningsExact identifier
application number: M020
Meijer SPF 50 Sunscreen CoconutAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMeijer40d15366-85b8-f5e8-e063-6294a90a5fd82025-10-10WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWasatch Product Development, LLCf4369f2f-fdc3-e48e-e053-2995a90a07f72025-10-10WarningsExact identifier
application number: M020
Sun Bum Face 50 Premium Sunscreen SPF 50AVOBENZONE, HOMOSALTE, OCTISALATE, OCTOCRYLENEWasatch Product Development, LLCf4ac746a-a50a-8041-e053-2a95a90a8ea62025-10-10WarningsExact identifier
application number: M020
Wonderscreen Broad Spectrum SPF 30ZINC OXIDEWasatch Product Development, LLC.e895d942-e50e-1ad6-e053-2995a90a0e022025-10-10WarningsExact identifier
application number: M020
MediChoice Moisturizing Lip Balm SPF15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEO&M HALYARD, INC.00327815-28f0-4198-bca7-c8ae768ff4162025-10-09WarningsExact identifier
application number: M020
Daybird 4-in-1 Skin Tint SerumZINC OXIDEResette, Inc.19c1a934-b0f5-1068-e063-6294a90a3b1f2025-10-09WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70157-027-017015700270160 mL in 1 BOTTLE, PLASTIC (70157-027-01) 60 ml2025-05-30NoNoCurrent
70157-027-0270157002702100 mL in 1 BOTTLE, PLASTIC (70157-027-02) 100 ml2025-05-30NoNoCurrent
70157-027-0370157002703250 mL in 1 BOTTLE, PLASTIC (70157-027-03) 250 ml2025-05-30NoNoCurrent
70157-027-0470157002704500 mL in 1 BOTTLE, PUMP (70157-027-04) 500 ml2025-05-30NoNoCurrent
70157-027-057015700270535 mL in 1 TUBE (70157-027-05) 35 ml2026-05-13NoNoCurrent