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 120 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY RIKI LLC387d5194-bc12-68c1-e063-6394a90ab1522025-12-15Exact identifier
application number: M020
Tinted Mineral Sun ProtectantTITANIUM DIOXIDE, ZINC OXIDEPANDA PAMPERING LLC387c23c2-a9f0-f484-e063-6394a90a41042025-12-15Exact identifier
application number: M020
Tinted Mineral Sun ProtectantTITANIUM DIOXIDE, ZINC OXIDEPANDA PAMPERING LLC387be96f-8cda-ce02-e063-6394a90abea52025-12-15Exact identifier
application number: M020
Serum Lightly TintedZINC OXIDEPANDA PAMPERING LLC387c593b-c65b-62b5-e063-6294a90ac4c22025-12-15Exact identifier
application number: M020
Serum Lightly TintedZINC OXIDEPANDA PAMPERING LLC387c9167-638c-1e30-e063-6394a90a93742025-12-15Exact identifier
application number: M020
REJUVN8TITANIUM DIOXIDE, ZINC OXIDEFLEUR DE VIE LLC37ede476-43b6-a7c8-e063-6294a90a3e8f2025-12-15Exact identifier
application number: M020
REJUVN8TITANIUM DIOXIDE, ZINC OXIDEFLEUR DE VIE LLC37efa5e1-e88e-d251-e063-6394a90a93712025-12-15Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE BEAUTY ROOM OC INC3dd330bf-92e4-3664-e063-6294a90a04752025-12-15WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE BEAUTY ROOM OC INC3dd37dd1-fd43-7af4-e063-6394a90ae3a02025-12-15WarningsExact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE BEAUTY ROOM OC INC3dd3dcab-e9fb-0ef5-e063-6394a90acef12025-12-15WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDETHE BEAUTY ROOM OC INC3dd40a6a-d52e-ab87-e063-6294a90a966e2025-12-15WarningsExact identifier
application number: M020
20 Zinc Oxide Non-Tinted Mineral SunscreenZINC OXIDEAGELESS SKINCARE INC3766e6c0-8976-509d-e063-6394a90af00f2025-12-15Exact identifier
application number: M020
20 Zinc Oxide Tinted Mineral SunscreenZINC OXIDEAGELESS SKINCARE INC3766b00f-ceda-a6f9-e063-6294a90aff5d2025-12-15Exact identifier
application number: M020
Mattifying Skin PrimerTITANIUM DIOXIDE, ZINC OXIDESKIN MAVEN37662032-2842-1982-e063-6294a90a49a02025-12-15Exact identifier
application number: M020
Moisturizing Face and Body SPFZINC OXIDESKIN MAVEN376645ee-7ea8-e738-e063-6394a90a119b2025-12-15Exact identifier
application number: M020
Mermaid Glow And Go Non Tinted Mineral SunscreenZINC OXIDEMermaid Glow LLC3985a298-fe0b-c296-e063-6294a90ab6c02025-12-15Exact identifier
application number: M020
Mermaid Glow And Go Non Tinted Mineral SunscreenZINC OXIDEMermaid Glow LLC39856675-c110-a7a7-e063-6294a90ac6af2025-12-15Exact identifier
application number: M020
Bio H Plus Daily Defense And RevitalizeZINC OXIDEBIOHEALTH PLUS LLC3764f723-cc7a-2128-e063-6294a90ac8942025-12-15Exact identifier
application number: M020
Extreme Protection Non TintedZINC OXIDEBIOHEALTH PLUS LLC37656077-5185-817a-e063-6394a90adf5a2025-12-15Exact identifier
application number: M020
Deluxe Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDEBIOHEALTH PLUS LLC37657895-5fec-82d0-e063-6294a90acf672025-12-15Exact 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