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 336 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Artistry Exact Fit Longwearing Foundation Shade Tawny L3N1TITANIUM DIOXIDEAmway Corp706e1504-fad7-44fa-9030-f5b948e3e79b2023-10-22WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Cappuccino L5W1TITANIUM DIOXIDEAmway Corpb785af89-1134-4fc6-8388-c47c52d153e02023-10-22WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Natural L2N2TITANIUM DIOXIDEAmway Corpdb24e10a-6957-4ce7-8b03-572caacc647a2023-10-22WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Caramel L5N1TITANIUM DIOXIDEAmway Corpe7d8616d-3e79-4b5e-b05b-fbb506c0203d2023-10-22WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Plush L3C1TITANIUM DIOXIDEAmway Corpff387c87-4ada-41c6-b62b-07a1432137702023-10-22WarningsExact identifier
application number: M020
Artistry Exact Fit Longwearing Foundation Shade Walnut L6N1TITANIUM DIOXIDEAmway Corp48c0bb8b-2f89-465e-9ae6-98690a2f877c2023-10-22WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Buff L1W1OCTINOXATE, OXYBENZONEAmway Corp11a8cc16-33f1-43d1-9f35-aa0f6e70adf62023-10-22WarningsExact identifier
application number: M020
CoreTex Sun X SPF 30 ThinAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONECoreTex Products Inc980388b5-8314-3143-e053-2995a90a72882023-10-22WarningsExact identifier
application number: M020
CoreTex Sun X SPF 30 Multipack NewAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECoreTex Productsf4ed9d7f-2d03-87d1-e053-2a95a90a3b4f2023-10-22WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Chablis L1C1OCTINOXATE, OXYBENZONEAmway Corp8cdf7dcf-c2fa-4e41-8d56-c4f6cebe0a902023-10-22WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Mink L6W1OCTINOXATE, OXYBENZONEAmway Corp429044b1-f7b8-4d1e-8360-0feb380161dd2023-10-22WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Cream L1W2OCTINOXATE, OXYBENZONEAmway Corpe7e89303-f399-46c7-a029-c6d3d0a2dc4e2023-10-22WarningsExact identifier
application number: M020
Artistry Skin Nutrition BALANCING Matte DayAVOBENZONE, OCTISALATE, OCTOCRYLENEAccess Business Group LLCd4a87153-7ef0-4365-ad91-dced9b1d80552023-10-21WarningsExact identifier
application number: M020
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen Light/MediumENSULIZOLE,OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAmway Corp830a748f-bb14-47f6-ab6f-48d8bd7063212023-10-21WarningsExact identifier
application number: M020
Artistry Skin Nutrition HYDRATING DayAVOBENZONE, OCTISALATE, OCTOCRYLENEAccess Business Group LLC06313228-7a79-48c5-8fd0-b210da6d037b2023-10-21WarningsExact identifier
application number: M020
Artistry Skin Nutrition RENEWING Reactivation Day SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEAccess Business Group LLCbd4818b3-d5db-4812-96ec-1bd91aa1508b2023-10-21WarningsExact identifier
application number: M020
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Med/DeepENSULIZOLE, OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAmway Corp20c432e2-4c63-485b-9dd5-2bc73b6f42852023-10-21WarningsExact identifier
application number: M020
Artistry Ideal Radiance Illuminating CC SPF50 Broad Spectrum Sunscreen - LightENSULIZOLE,OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAccess Business Group LLC070f9538-4b36-471a-aa06-6669e9ecfdf02023-10-21WarningsExact identifier
application number: M020
Artistry Ideal Radiance Illuminating CC SPF 50 Broad Spectrum Sunscreen MediumENSULIZOLE,OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAmway Corp40a82d20-b84b-4ae8-818d-1f503ceef5812023-10-21WarningsExact identifier
application number: M020
Artistry Skin Nutrition RENEWING Reactivation Day Cream SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEAccess Business Group LLC4a0af0e9-04da-4b5f-a57a-967bef7257892023-10-21WarningsExact 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