FDA.reportPublic FDA data

RMS SUNCOVERUP SUPER TINT SPF 50 BUFF

Product NDC
83249-005
11-digit product format
832490005
Labeler code
83249
Product ID
83249-005_1a11c884-d6bb-d77f-e063-6394a90a5bd2
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 BUFF
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
1a11c884-d6ba-d77f-e063-6394a90a5bd2Available 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
83249-005-01RMS SUNCOVERUP SUPER TINT SPF 50 BUFF1 in 1 CARTONLOTION11
83249-005-01RMS SUNCOVERUP SUPER TINT SPF 50 BUFF30 mL in 1 BOTTLE, GLASSLOTION301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83249-005RMS SUNCOVERUP SUPER TINT SPF 50 IVORY (ZINC OXIDE) LOTION RMS SUNCOVERUP SUPER TINT SPF 50 HONEY (ZINC OXIDE) LOTION RMS SUNCOVERUP SUPER TINT SPF 50 CAMEO (ZINC OXIDE) LOTION RMS SUNCOVERUP SUPER TINT SPF 50 BUFF (ZINC OXIDE) LOTION RMS SUNCOVERUP SUPER TINT SPF 50 ALABASTER (ZINC OXIDE) LOTION RMS SUNCOVERUP SUPER TINT SPF 50 CARAMEL (ZINC OXIDE) LOTION [RMS ORGANICS LLC]1Current NDC, 2 package rows20240901_1a11c884-d6ba-d77f-e063-6394a90a5bd2.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 239 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay AgelessTinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEPURA VIDA BODY & MIND SPA, INC.04b38e97-c4b3-df23-e063-6394a90ae6b72025-01-08WarningsExact identifier
application number: M020
EVEN DEFENSE Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEPremier Plastic Surgerybc9221fe-89b4-4ad8-e053-2995a90aa0412025-01-08WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEEmerald Aesthetics LLCf80f439d-f4f0-fbf3-e053-6294a90ae0ef2025-01-08WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDESuzanne's Skin2soul LLCfea667a1-6bec-9819-e053-6394a90a9b962025-01-08WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEBEAUTY SENSE MEDSPA INCfe93a337-8d2f-35d3-e053-6294a90acb3c2025-01-08WarningsExact identifier
application number: M020
Sunscreen Emulsion SPF50plusOCTOCRYLENE,ETHYLHEXYL METHOXYCIRNNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATEGuangzhou Senmai Biotechnology Co.1d560670-026b-bd34-e063-6394a90a9af42025-01-08WarningsExact identifier
application number: M020
Allies of Skin Sunless Tan SPF 50 Daily Self TannerAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEALLIES GROUP PTE. LTD.4d58de8e-875b-4b77-b0ef-b9d760aaced82025-01-07WarningsExact identifier
application number: M020
Pop Zinc SunscreenZINC OXIDEGuangzhou Haishi Biological Technology Co., Ltd2b29ddb2-5730-8a67-e063-6394a90ae4162025-01-07WarningsExact identifier
application number: M020
COOLA Anti-Aging Sun Silk Drops Sunscreen SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENE SUNSCREEN SERUMCOOLA LLCbbb29d0c-ae1f-409e-8fd6-ff3ea34dc9c22025-01-07WarningsExact identifier
application number: M020
Advanced Day Ultimate Protect Sunscreen SPF 50BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATEMedik8 Limited29071920-ba90-871a-e063-6294a90aee272025-01-06WarningsExact identifier
application number: M020
Dimples Bath Co - Sunstick New Kid On The BlockZINC OXIDEDimples Bath Co. LLC26f682f4-2440-f111-e063-6294a90ab4b72025-01-06WarningsExact identifier
application number: M020
Diaper Rash Cream Happy CheeksDIAPER RASH HAPPY CHEEKSDimples Bath Co. LLC26cef2eb-a133-11ec-e063-6394a90a0f082025-01-06WarningsExact identifier
application number: M020
New Kid on the BlockZINC OXIDEDimples Bath Co. LLC26fec959-c234-6692-e063-6394a90a66002025-01-06WarningsExact identifier
application number: M020
New Kid on the BlockZINC OXIDEDimples Bath Co. LLC26f85758-820f-3f73-e063-6294a90a289d2025-01-06WarningsExact identifier
application number: M020
Bondi Sands SPF 60 Sunny Spritz Face MistHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEBONDI SANDS (USA) INC.2b0f0b56-233f-4c6a-e063-6394a90aea6f2025-01-06WarningsExact identifier
application number: M020
Bondi Sands SPF 60 Sunny Spritz Body MistHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEBONDI SANDS (USA) INC.2b0fe721-b92a-4181-e063-6394a90a846a2025-01-06WarningsExact identifier
application number: M020
sunbetter Broad Spectrum SPF 56 Sunscreen Stick SheerZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLC92c4e4cb-aadc-26f4-e053-2995a90a03d52025-01-06WarningsExact identifier
application number: M020
sunbetter Broad Spectrum SPF 56 Sunscreen Compact SheerZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLCb8a4986d-c28f-c4f4-e053-2a95a90a71672025-01-06WarningsExact identifier
application number: M020
sunbetter Broad Spectrum SPF 68 Sunscreen Compact Tone SmartZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLC8f119447-045b-43f3-e053-2995a90aea772025-01-06WarningsExact identifier
application number: M020
sunbetter Broad Spectrum SPF 75 Sunscreen Tone SmartZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLCb878ee3b-6897-3c4a-e053-2995a90afed72025-01-06WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83249-005-01832490005011 BOTTLE, GLASS in 1 CARTON (83249-005-01) / 30 mL in 1 BOTTLE, GLASS2024-09-01NoNoCurrent