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 275 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Health Sport SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf799bad7-b3df-f9a5-e053-6294a90ab1042024-10-17WarningsExact identifier
application number: M020
CVS Health SPF 30 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYf41e145c-896e-2782-e053-2995a90a5f812024-10-17WarningsExact identifier
application number: M020
CVS Health AM Moisturizing Facial Broad Spectrum SPF 30 SunscreenHOMOSALATE, OCTOCRYLENE, ZINC OXIDECVS PHARMACYf9c89108-1568-ee3e-e053-6294a90ac7562024-10-17WarningsExact identifier
application number: M020
CVS Health 50 Clear Zinc Broad Spectrum SPF 50 SunscreenOCTOCRYLENE, ZINC OXIDECVS PHARMACYfa19e9d3-6ab8-cbd6-e053-6294a90aae9b2024-10-17WarningsExact identifier
application number: M020
CVS Health Sport 30 ClearAVOBENZONE, HOMOSALATE, OCTOCRYLENECVS PHARMACYfbe6ae15-28ef-2acf-e053-6394a90a8d422024-10-17WarningsExact identifier
application number: M020
CVS Health 45 Ultra SheerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS Pharmacyfc4addf0-9a6e-292f-e053-6294a90ab9c02024-10-17WarningsExact identifier
application number: M020
CVS Health Sport 70AVOBENZONE. HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACYfc4a79ce-208e-2aed-e053-6394a90a06bb2024-10-17WarningsExact identifier
application number: M020
CVS Health Sport 70 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENECVS PHARMACYfc4bbb80-c3f6-c4f7-e053-6394a90a4cae2024-10-17WarningsExact identifier
application number: M020
SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDEMOULAS SUPER MARKETS, INCee782436-9eff-49e4-8edc-fd9783454c072024-10-17WarningsExact identifier
application number: M020
GLOW RECIPE WATERMELON GLOW DEW BALM SPF 45AVOBENZONE, HOMOSALATE, OCTISALATEAramara Beauty LLC dba Glow Recipe0c437f88-c731-5834-e063-6394a90a32992024-10-17WarningsExact identifier
application number: M020
SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDEMOULAS SUPER MARKETS, INC5ce3e436-37d1-4918-bb14-0be33b0bc86a2024-10-17WarningsExact identifier
application number: M020
MARKET BASKET KIDS SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDEMOULAS SUPER MARKETS, INC.a6a381da-6e34-bffe-e053-2a95a90a46f22024-10-17WarningsExact identifier
application number: M020
Market Basket Continuous Sunscreen SPF 50AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEDEMOULAS SUPER MARKETS, INC.f4238107-c76c-266a-e053-2a95a90a89782024-10-17WarningsExact identifier
application number: M020
Market Basket Continuous Sunscreen General Protection SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENEDEMOULAS SUPER MARKETS, INC.e7182d07-a006-db4b-e053-2995a90aa9e12024-10-17WarningsExact identifier
application number: M020
EXCHANGE SELECT SPORT SUNSCREEN CONTINUOUS SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEArmy & Air Force Exchange Servicee467df80-9007-46c9-e053-2a95a90a1bef2024-10-17WarningsExact identifier
application number: M020
EXCHANGE SELECT KIDS SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEArmy & Air Force Exchange Servicee467c306-a2ed-4976-e053-2995a90a56ed2024-10-17WarningsExact identifier
application number: M020
Exchange Select Sport Sunscreen Continuous SPF 70AVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENEArmy & Air Force Exchange Servicee716ba8c-0148-07f2-e053-2a95a90a53df2024-10-17WarningsExact identifier
application number: M020
EXCHANGE SELECT SPORT SUNSCREEN CONTINUOUS SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEArmy & Air Force Exchange Servicef55828b4-f2a4-13ec-e053-2995a90a0f842024-10-17WarningsExact identifier
application number: M020
SPF50 Plus Mineral SunscreenZINC OXIDE AND TITANIUM DIOXIDEKAS Direct LLC dba BabyGanics08e8bc10-85d8-4215-8351-7ec12029416c2024-10-17WarningsExact identifier
application number: M020
bu SPF 30 Broad Spectrum Alcohol-Free Performance Sunscreen - Natural Citrus ScentOCTINOXATE, OCTOCRYLENE, OCTISALATE, AND AVOBENZONEBu Brands, LLC9ac92c96-5bcf-421d-9cd0-73ddfa10195c2024-10-17WarningsExact 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