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 63 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
All Day MoistureHOMOSALATE, ZINC OXIDEWalmart Inc.b45d0ab6-b14d-4e3e-807a-886e6fffdded2026-02-11Warnings, Adverse reactionsExact identifier
application number: M020
Ganrek SUNSCREEN SPRAYER Broad Spectrum SPF 50SUNSCREEN SPF 50Guangzhou Meixi Biotechnology Co., Ltd.4a3adb04-5e3a-80bf-e063-6294a90a60472026-02-10WarningsExact identifier
application number: M020
Sugargirl Glow Up Body Illuminator Shimmer Sunscreen SPF 30HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC364d4d87-2d3e-4515-a3f2-1506d871699d2026-02-10WarningsExact identifier
application number: M020
Sugargirl Sunshine Body Illuminator Glowy Sunscreen SPF 30HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLCea801e6c-44f9-4ec9-9022-5b637baf7d592026-02-10WarningsExact identifier
application number: M020
Poolside Golden Hour SPF 15 Sunscreen LipHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC7d0f8319-f0fa-4ea7-bb66-427c5a78145a2026-02-10WarningsExact identifier
application number: M020
Tanri Broad Spectrum SPF 30SUNSCREENI. Shay Cosmetics26d5b9d1-d669-3430-e063-6394a90ad7f22026-02-10WarningsExact identifier
application number: M020
DAILY SUNSCREEN BROAD SPECTRUM SPF 30ZINC OXIDES+9d6ffe56-debc-4ad2-837b-fd7bb091a56f2026-02-09WarningsExact identifier
application number: M020
Alumier MD Clear Shield Broad Spectrum SPF 42 SunscreenTITANIUM DIOXIDE, ZINC OXIDEAlumier Labsa9c970c8-b6e3-b0a1-e053-2a95a90a89c72026-02-09WarningsExact identifier
application number: M020
Solavida Broad Spectrum Mineral Sunscreen SPF 30 - FaceZINC OXIDESolavida, LLC4a694cdf-496b-3bc0-e063-6294a90af0d12026-02-09WarningsExact identifier
application number: M020
numbuzin 9 NAD BIO Super Defense Glow Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBENOW BEAUTY INC32bfb17c-5535-c016-e063-6394a90a18142026-02-09WarningsExact identifier
application number: M020
TRADER JOES SHIMMER SUNSCREEN BROAD SPECTRUM SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Company4a6b69ed-2739-d22a-e063-6294a90a1e522026-02-09WarningsExact identifier
application number: M020
SUNPLUS LIP LIFESUNSCREENI. Shay Cosmetics26d28286-e812-0fb3-e063-6394a90a338d2026-02-09WarningsExact identifier
application number: M020
NUDESCREEN DEWY ILLUMINATING GLOW SPF 30 - Goddess GlowZINC OXIDE SUNSCREENBentley Laboratories, LLCbb86322d-ff30-4a54-97b5-1be2750671462026-02-06WarningsExact identifier
application number: M020
Hampton Sun SPF 50 MineralZINC OXIDE 19.5% TITANIUM DIOXIDE 4.00%S&C Hampton Sun LLCd6c33436-042e-44e8-8b55-98be6e2468792026-02-06WarningsExact identifier
application number: M020
SHISEIDO WASO COLOR-SMART DAY MOISTURIZEROCTINOXATE, TITANIUM DIOXIDEShiseido Americas Corporationf291f077-1c72-48fc-bb19-c20bdeaaa5962026-02-06WarningsExact identifier
application number: M020
SHISEIDO WASO SHIKULIME COLOR CONTROLAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE,Shiseido Americas Corporationf225a736-2ff7-4084-88a4-a8df5b043cce2026-02-06WarningsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAmerican Sales Company79dff6ec-d958-4bba-999b-da4aa67519f52026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, Octisalate, OctocryleneSUNSCREENRetail Business Services, LLC1dc325bb-d520-4897-b8f8-3f0ecba2274c2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Sheer Touch Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLCd8a55217-ae50-4c7f-a440-f4de079d08ae2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Sheer Touch Sunscreen SPF 100AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLCf2a4b432-118e-42a4-baeb-90614dccbd062026-02-06Warnings, Adverse reactionsExact 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