FDA.reportPublic FDA data

RMS SUNCOVERUP SUPER TINT SPF 50 TOFFEE

Product NDC
83249-016
11-digit product format
832490016
Labeler code
83249
Product ID
83249-016_1a1adc41-a8d9-5415-e063-6394a90aabb3
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Rms organics LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-01
Substance
ZINC OXIDE
Active strength
120 mg/mL
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
RMS SUNCOVERUP SUPER TINT SPF 50 TOFFEE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE120 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1a1aebea-ed0c-ac92-e063-6294a90aeae6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83249-016-01RMS SUNCOVERUP SUPER TINT SPF 50 TOFFEE1 in 1 CARTONLOTION11
83249-016-01RMS SUNCOVERUP SUPER TINT SPF 50 TOFFEE30 mL in 1 BOTTLE, GLASSLOTION301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83249-016RMS SUNCOVERUP SUPER TINT SPF 50 TAWNY (ZINC OXIDE) LOTION RMS SUNCOVERUP SUPER TINT SPF 50 TAN (ZINC OXIDE) LOTION RMS SUNCOVERUP SUPER TINT SPF 50 SAND (ZINC OXIDE) LOTION RMS SUNCOVERUP SUPER TINT SPF 50 MOCHA (ZINC OXIDE) LOTION RMS SUNCOVERUP SUPER TINT SPF 50 MAHOGANY (ZINC OXIDE) LOTION RMS SUNCOVERUP SUPER TINT SPF 50 SPICE (ZINC OXIDE) LOTION RMS SUNCOVERUP SUPER TINT SPF 50 TOFFEE (ZINC OXIDE) LOTION [RMS ORGANICS LLC]1Current NDC, 2 package rows20240901_1a1aebea-ed0c-ac92-e063-6294a90aeae6.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 264 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
I Conceal Flawless Foundation Broad Spectrum SPF 30 Sunscreen MahoganyZINC OXIDE AND TITANIUM DIOXIDEAllure Labsdcba05ff-7a68-c5c0-e053-2a95a90a61292024-12-09WarningsExact identifier
application number: M020
Prevention Daily Matte Moisturizer SPF 30ZINC OXIDE AND HOMOSALATEAllure Labsf0fb1b69-53f2-efff-e053-2995a90af9d42024-12-09WarningsExact identifier
application number: M020
MD Restoring daily Defense Moisturizer SPF 50ZINC OXIDE AND TITANIUM DIOXIDEAllure Labs Inceb8e7109-b5eb-5cc1-e053-2995a90a486f2024-12-09WarningsExact identifier
application number: M020
Prevention Sun Serum SPF 30 TintedZINC OXIDEAllure Labsf1761b09-9061-a052-e053-2a95a90a39c82024-12-09WarningsExact identifier
application number: M020
Prevention Sun Serum SPF30ZINC OXIDEAllure Labsf188669f-7b9f-6e01-e053-2995a90afa3c2024-12-09WarningsExact identifier
application number: M020
Prevention Clear Solar Gel SPF30AVOBENZON, OCTISALATE AND OCTOCRYLENEAllure LAbsf19f6d9b-5249-27a6-e053-2a95a90a8a392024-12-09WarningsExact identifier
application number: M020
OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen TintedZINC OXIDEAllure Labs02e7fb00-2039-c4f8-e063-6294a90a418f2024-12-09WarningsExact identifier
application number: M020
OneSkin OS-01 SHIELD Broad Spectrum SPF 30 Mineral Sunscreen UntintedZINC OXIDEAllure Labs02f9c859-8d7d-5146-e063-6394a90a57b52024-12-09WarningsExact identifier
application number: M020
Quench and Protect Hydrating SPF30ZINC DIOXIDE AND TITANIUM DIOXIDEAllure Labs.039e50c1-7b3d-d392-e063-6394a90a4b3c2024-12-09WarningsExact identifier
application number: M020
Tinted Face Cream SPF 15OCTOCRYLENE, OCTISALATEBentley Laboratories, LLC0d7300ee-adf4-41be-bb9f-257cd2986c0f2024-12-06WarningsExact identifier
application number: M020
Derm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF50TITANIUM DIOXIDE, ZINC OXIDEBeautcella Inc.bad942d8-04da-31d2-e053-2a95a90a92752024-12-06WarningsExact identifier
application number: M020
TOM FORD ARCHITECTURE RADIANCE HYDRATING FOUNDATION BROAD SPECTRUM SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDETOM FORD BEAUTY DIST289b824f-bb0b-313e-e063-6394a90ab7832024-12-06WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral Sunscreen Stick Orange Blossom SPF 30ZINC OXIDE9055-7588 Quebec Inc. DBA Attitude0d840001-a648-df1b-e063-6294a90ab2992024-12-06WarningsExact identifier
application number: M020
Performance Face Sunscreen Broad Spectrum SPF 30ZINC OXIDE, OCTOCRYLENE, OCTISALATEBentley Laboratories, LLC1629f061-b8fc-4fda-8378-c64e164d41bd2024-12-06WarningsExact identifier
application number: M020
Clear System Brightening Day Cream SPF 15OCTOCRYLENE, OCTISALATEBentley Laboratories, LLC8cbc8fa4-469f-4fa3-bd8e-27e815989c3f2024-12-06WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB Cream SPF42 (No. 25)ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.604e7a49-7986-11ee-e053-2a91aa0a1bee2024-12-05WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB No 27ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.c4e16cec-c7db-4e5e-9d05-5d7afdb790912024-12-05WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB SPF42 No29OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDEAble C&C Co., Ltd.3fc90114-4cdf-273e-e054-00144ff8d46c2024-12-05WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB No 31ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.95862d15-d977-7276-e053-2995a90ab6902024-12-05WarningsExact identifier
application number: M020
MISSHA M Perfect Cover BB Cream SPF42 No. 25ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATEAble C&C Co., Ltd.9c6f48b1-007b-434f-b756-242e3390e9b72024-12-05WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83249-016-01832490016011 BOTTLE, GLASS in 1 CARTON (83249-016-01) / 30 mL in 1 BOTTLE, GLASS2024-09-01NoNoCurrent