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 341 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bareMinerals Original Foundation Broad Spectrum SPF 15 Golden Fair 04TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLCe486915b-8097-451a-a018-3279213239b32023-10-04WarningsExact identifier
application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Deepest Deep 30ZINC OXIDEOrveon Global US LLC4054b48e-d8be-4542-9b43-4437c250579b2023-10-04WarningsExact identifier
application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Golden Deep 28TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC5b51df09-40c3-4064-96d3-b7366fc838262023-10-04WarningsExact identifier
application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Fairly Medium 05TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLCf1714e23-030c-4bd9-b9e7-111c3813ed342023-10-04WarningsExact identifier
application number: M020
bareMinerals Original Foundation Broad Spectrum SPF 15 Medium Dark 23TITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC828fe263-f223-45c3-9710-fd8d59ad56b12023-10-04WarningsExact identifier
application number: M020
bareMinerals Multi-Tasking SPF 20 Concealer BisqueTITANIUM DIOXIDEOrveon Global US LLCd4c30bea-8c56-4ed8-8ec4-f1b1e0e456dd2023-10-04WarningsExact identifier
application number: M020
BareMinerals Mineral VeilTITANIUM DIOXIDE AND ZINC OXIDEOrveon Global US LLC64b163dd-8a86-483f-8dab-80fa8740b12f2023-10-04WarningsExact identifier
application number: M020
Laura Mercier Pure Canvas Primer Protecting Broad Spectrum SPF 30 SunscreenOCTINOXATE, OCTOCRYLENE, AVOBENZONE, AND OXYBENZONELaura Mercier US Buyer LLCe7903f3d-9c59-f397-e053-2995a90a78952023-10-04WarningsExact identifier
application number: M020
Laura Mercier Tinted Moisturizer Light Revealer Natural Skin Illuminator Broad Spectrum SPF 25 Sunscreen 0N1 PetalAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENELaura Mercier US Buyer LLCe78e17bf-5606-1031-e053-2a95a90adb352023-10-04WarningsExact identifier
application number: M020
Laura Mercier Tinted Moisturizer Natural Skin Perfector Broad Spectrum SPF 30 Sunscreen 0N1 PetalAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONELaura Mercier US Buyer LLCe78f9689-2f8b-1524-e053-2995a90adc792023-10-04WarningsExact identifier
application number: M020
Laura Mercier Flawless Skin Repair Day Creme Broad Spectrum SPF 15 SunscreenAVOBENZONE, OCTINOXATE, AND OXYBENZONELaura Mercier US Buyer LLCe931d389-6b3d-5a7d-e053-2a95a90a7aa32023-10-04WarningsExact identifier
application number: M020
BANANA BOATZINC OXIDEEdgewell Personal Care Brands LLC05bbe530-df26-e598-e063-6394a90a0c592023-10-03WarningsExact identifier
application number: M020
Native Facial Care Brightening Facial Moisturizer Broad Spectrum SPF 30ZINC OXIDEThe Procter & Gamble Manufacturing Companyded27678-0df8-deda-e053-2a95a90a06582023-09-28WarningsExact identifier
application number: M020
CLEAR IMPROVEMENT PORE CLEARING MOISTURIZERSALICYLIC ACIDORIGINS NATURAL RESOURCES INC.6f9d87fb-2026-4226-b182-ff2a3c40460d2023-09-12WarningsExact identifier
application number: M020
DR ANDREW WEILS FOR ORIGINS MEGA-DEFENSE ADVANCED DAILY UV DEFENDER BROAD SPECTRUM SPF 45TITANIUM DIOXIDE AND ZINC OXIDEORIGINS NATURAL RESOURCES INC.11248cab-c3a5-4e16-8280-9f70bb863cf72023-09-11WarningsExact identifier
application number: M020
PLANTSCRIPTION SPF 25 POWER ANTI AGING BROAD SPECTRUM 25AVOBENZONE, HOMOSALATE, OCTISLATE, AND OCTOCRYLENEORIGINS NATURAL RESOURCES INC.c706fed8-f215-4c53-bfc5-2bd87b8f884e2023-09-11WarningsExact identifier
application number: M020
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
application number: M020
Anubis Barcelona Protective LineETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENEANUBIS COSMETICS SLec83846f-11c0-8f59-e053-2995a90ab9d22023-09-01WarningsExact identifier
application number: M020
eos Natural SPF 15 Lip Balm Pineapple CoconutZINC OXIDEeos Products LLC039ca738-c2c1-41c8-e063-6394a90ab4c42023-08-23WarningsExact identifier
application number: M020
Safeguard SPF 40ZINC OXIDESkinsalvation Skincare, Inc.4730721b-6148-4a80-a749-13c4febf2e382023-07-14WarningsExact 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