FDA.reportPublic FDA data

Tula Skincare Protect and Glow Daily Facial Sunscreen Gel SPF 30

Product NDC
84126-103
11-digit product format
841260103
Labeler code
84126
Product ID
84126-103_5634bca7-9eca-c80b-e063-6294a90a1b58
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, and Octisalate
Dosage form
GEL
Route
TOPICAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength
3; 10; 5 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
Tula Skincare Protect and Glow Daily Facial Sunscreen Gel SPF 30
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
30a063fa-e537-a2c1-e063-6394a90a6a83Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-103-10Tula Skincare Protect and Glow Daily Facial Sunscreen Gel SPF 301 in 1 CARTONGEL11
84126-103-10Tula Skincare Protect and Glow Daily Facial Sunscreen Gel SPF 30100 mL in 1 TUBEGEL1001
84126-103-50Tula Skincare Protect and Glow Daily Facial Sunscreen Gel SPF 3050 mL in 1 TUBEGEL501
84126-103-50Tula Skincare Protect and Glow Daily Facial Sunscreen Gel SPF 301 in 1 CARTONGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-103TULA SKINCARE PROTECT AND GLOW DAILY FACIAL SUNSCREEN GEL SPF 30 (AVOBENZONE, HOMOSALATE, AND OCTISALATE) GEL [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC, 4 package rows20250322_30a063fa-e537-a2c1-e063-6394a90a6a83.zip

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 243 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REVLON AGE DEFYING FIRMING LIFTING MAKEUP SPF 15OCTINOXATE, TITANIUM DIOXIDE MAKE-UPRevlon Consumer Products Corpd9209277-469d-48f4-bf64-f39a70c195962024-12-31WarningsExact identifier
application number: M020
Almay Smart Shade Skintone Matching Makeup LightTITANIUM DIOXIDE ZINC OXIDEAlmay, Inc.2a987b85-efdb-eb95-e063-6394a90aef812024-12-31WarningsExact identifier
application number: M020
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 LightTITANIUM DIOXIDE, ZINC OXIDEAlmay, Inc.2a984dd9-7293-77f0-e063-6294a90a8f1e2024-12-31WarningsExact identifier
application number: M020
Vichy Laboratoires Capital Soleil 50 Daily AntiAging Face Sunscreen Broad Spectrum SPF 50 Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENELOreal USA Products Inc097fc15e-ea17-47b2-9581-19c5e11592f62024-12-30WarningsExact identifier
application number: M020
HERBAL UV DEFENSE SPF40HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENECOSMAX USA, CORPORATION2a76fd94-2f1f-e6d8-e063-6294a90a287c2024-12-30WarningsExact identifier
application number: M020
Almay Healthy Biome MakeupHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEAlmayab20969a-8640-307d-e053-2a95a90a004d2024-12-30WarningsExact identifier
application number: M020
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUSOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEExelencia importers Corp.2a845e4c-86e7-1799-e063-6294a90a9b2b2024-12-30WarningsExact identifier
application number: M020
American Crew All In One Face Balm Broad Spectrum SPF 15OCTISALATE,HOMOSALATE,AVOBENZONE,OCTOCRYLENERevlon Consumer Products Corp012be422-1b4c-443c-9484-02efc744296d2024-12-30WarningsExact identifier
application number: M020
Advanced Ceramide Lift and Firm Day Cream Broad Spectrum Sunscreen SPF 15OCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATEREVLON2a857553-5ad0-a0e2-e063-6294a90af4352024-12-30WarningsExact identifier
application number: M020
SkinCeuticals Sheer Physical UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc2035ab03-80b4-49f4-b379-eb8bc42c9cee2024-12-30WarningsExact identifier
application number: M020
PRISMA PROTECT SPF30HOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEDermalogica, LLC.713bad2e-bf32-4cd5-9630-b8d88d4376862024-12-30WarningsExact identifier
application number: M020
Protection 50 SportHOMOSALATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEDermalogica, LLC.e9ace96a-7717-4f5a-8e1b-1f56f74985992024-12-30WarningsExact identifier
application number: M020
SkinCeuticals Physical Matte UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Incb137b3d0-212b-440a-b158-62ace4b4eff32024-12-30WarningsExact identifier
application number: M020
SkinCeuticals Physical UV Defense Broad Spectrum SPF 30 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc3a6db7d3-6c59-4633-a97e-1c03127246d32024-12-30WarningsExact identifier
application number: M020
Dermablend Professional Leg and Body Makeup Broad Spectrum SPF 25 SunscreenOCTISALATE AND OCTOCRYLENEL'Oreal USA Products Incdf62e1c2-ce72-4ded-8985-156dce9ff41d2024-12-28WarningsExact identifier
application number: M020
LOreal Paris Revitalift Derm Intensives Invisible UV Fluid Broad Spectrum SPF 50 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Inc02dddfc5-61e6-433b-8d6d-a17bf3fc8ed62024-12-28WarningsExact identifier
application number: M020
Vichy Laboratoires Aqualia Thermal UV Defense Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENECosmetique Active Production229eef79-39ae-4395-8100-64d1ece960d22024-12-28WarningsExact identifier
application number: M020
COOLA Mineral Sun Silk Creme Sunscreen SPF 30ZINC OXIDECOOLA LLCbb9dd9a9-ec01-4e94-9172-3a72e68a417a2024-12-27WarningsExact identifier
application number: M020
Bare Republic Mineral SPF 50ZINC OXIDECOOLA LLC6a0db9da-ee45-4ab7-80de-4bf189efe75f2024-12-27WarningsExact identifier
application number: M020
COOLA CLASSIC BODY SUNSCREEN Guava Mango Broad Spectrum SPF 50AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENECOOLA LLC9a397a2c-4734-4dae-93dd-15c68e6c297d2024-12-27WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-103-10841260103101 TUBE in 1 CARTON (84126-103-10) / 100 mL in 1 TUBE1 tube2024-01-01NoNoCurrent
84126-103-50841260103501 TUBE in 1 CARTON (84126-103-50) / 50 mL in 1 TUBE1 tube2024-01-01NoNoCurrent