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 98 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eucerin Daily HydrationAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inc798cbf7f-b93d-49c8-b1c1-216486e57ea52025-12-31WarningsExact identifier
application number: M020
Eucerin Face immersive HydrationAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Incfe0b3717-f472-3a61-e053-6394a90a44fb2025-12-31WarningsExact identifier
application number: M020
NIVEA MEN Age Defense Face MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inc27cbec3e-e811-6498-e063-6394a90ada492025-12-31WarningsExact identifier
application number: M020
Nivea Men Maximum Hydration FaceAVOBENZONE, OCTISALATE, OCTOCRYLENEBeiersdorf Incf1276b11-6683-e982-e053-2a95a90a78032025-12-31WarningsExact identifier
application number: M020
Nivea Men Sensitive ProtectiveAVOBENZONE, OCTISALATE, OCTOCRYLENEBeiersdorf Incf6cff3d1-cca5-4b3e-a481-0c4def90684c2025-12-31WarningsExact identifier
application number: M020
Nivea Smoothness Lip CareAVOBENZONE,OCTOCRYLENEBeiersdorf Incc28e327d-ad39-9bd6-e053-2a95a90a04eb2025-12-31WarningsExact identifier
application number: M020
BOTANICAL SOOTHING SPF-30OCTINOXATE, OCTISALATE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INC00a923fe-e6da-420e-a705-4773ecc2176b2025-12-31WarningsExact identifier
application number: M020
AROMA MATTE DAY SUNSCREEN SPF-30OCTINOXATE, OCTISALATE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INCf822f3ec-3c57-100a-e053-6294a90ab0ec2025-12-31WarningsExact identifier
application number: M020
CONTROL CORRECTIVE TINTED MOISTURIZER SPF-30 SUNSCREENTITANIUM DIOXIDE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INC8ac09149-f7e7-40a8-b306-98964d0cd6e32025-12-31WarningsExact identifier
application number: M020
CONTROL CORRECTIVE SUNSCREEN SPF-30OCTINOXATE, OCTISALATE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INCe389b2bc-bb1c-443a-9bf6-c6d96380f3782025-12-31WarningsExact identifier
application number: M020
CONTROL CORRECTIVE INTENSIVE SKIN BRIGHTENING SPF-30 SUNSCREENOCTINOXATE, OCTISALATE, ZINC OXIDECONTROL CORRECTIVE SKINCARE INC61b6dab9-3378-4206-bf1f-6f385a9c882c2025-12-31WarningsExact identifier
application number: M020
Blue Lizard Sensitive SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories32d78048-d281-1d80-e063-6394a90aec192025-12-31WarningsExact identifier
application number: M020
DAYWEAR ANTI OXIDANT 72H-HYDRATION SORBET CREME BROAD SPECTRUM SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEESTEE LAUDER INCdf535004-c94c-4a28-ad20-78bd1741e39f2025-12-31WarningsExact identifier
application number: M020
FUTURIST SKIN TINT SERUMOCTINOXATE,OCTISALATE,ZINC OXIDEESTEE LAUDER INCea21e5a5-69d6-2de4-e053-2995a90a93b42025-12-31WarningsExact identifier
application number: M020
Dr.Jart Cicapair Tiger Grass Color Correcting TreatmentZINC OXIDE, TITANIUM DIOXIDEHave & Be Co., Ltd.40f96baf-0359-4d68-801f-68562c9094462025-12-31WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Fair-LightZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.b38b1b64-b433-4e11-9cf6-2108a552d1392025-12-31WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Light Medium-MediumZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.45b1c2c6-a45b-4a45-bec9-e5341079c0a12025-12-31WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Medium-TanZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.28a2ba45-1eff-488c-aae4-362b9f78b8df2025-12-31WarningsExact identifier
application number: M020
Dr.Jart Premium Beauty Balm Deep Tan-DeepZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATEHave & Be Co., Ltd.3c346960-b76b-4241-a188-8ee6948530782025-12-31WarningsExact identifier
application number: M020
DR.JART CICAPAIR TIGER GRASS CAMO DROPSZINC OXIDE, TITANIUM DIOXIDEHave & Be Co., Ltd.f06348f5-4ebc-325b-e053-2a95a90ada522025-12-31WarningsExact 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