FDA.reportPublic FDA data

RMS REFRESH EYE BRIGHTENER SPF 30 BROAD SPECTRUM SUNSCREEN SWOON

Product NDC
83249-020
11-digit product format
832490020
Labeler code
83249
Product ID
83249-020_3d3853b3-1ef5-2bf8-e063-6394a90a435b
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
EMULSION
Route
TOPICAL
Labeler
Rms organics LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-13
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 REFRESH EYE BRIGHTENER SPF 30 BROAD SPECTRUM SUNSCREEN SWOON
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
3d386cc9-e097-dacf-e063-6294a90a8fe2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83249-020-01RMS REFRESH EYE BRIGHTENER SPF 30 BROAD SPECTRUM SUNSCREEN SWOON1 in 1 CARTONEMULSION11
83249-020-01RMS REFRESH EYE BRIGHTENER SPF 30 BROAD SPECTRUM SUNSCREEN SWOON11.5 mL in 1 TUBEEMULSION11.51

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 334 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Babo Botanicals Sensitive Baby Mineral Sunscreen SPF50ZINC OXIDEBabo Botanicals, Inc.088b81e4-76c7-6680-e063-6294a90acb732023-10-25WarningsExact identifier
application number: M020
Cetaphil Hydrating Face Sunscreen SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGalderma Laboratories, L.P.e924bfd5-d64d-4918-b57b-7d4da28bd0132023-10-24WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Ochre L2N1OCTINOXATE, OXYBENZONEAmway Corpd810bbe7-a889-4737-9a78-d996fec711222023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Chiffon L2C1OCTINOXATE, OXYBENZONEAmway Corp0039ca4d-2a0c-4b19-a029-1c080fc292ce2023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Sand L2W1OCTINOXATE, OXYBENZONEAmway Corp410592f1-57f5-4c17-8162-a0c088f0bf272023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Tawny L3N1OCTINOXATE, OXYBENZONEAmway Corpe4e61943-ec96-467c-8921-ee531ef4f13d2023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Brule L4W1OCTINOXATE, OXYBENZONEAmway Corp62ff0eea-b67e-476c-b7f2-0fcaed9dc2272023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Cappuccino L5W1OCTINOXATE, OXYBENZONEAmway Corp179e5268-8eca-40b7-aa7f-ede221fa9c892023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Walnut L6N1OCTINOXATE, OXYBENZONEAmway Corp8a3fcfaa-5bfa-4f77-932f-bfb75628c9c62023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Soleil L3W1OCTINOXATE, OXYBENZONEAmway Corp18c11289-9cc0-4a37-a299-ee3c358dbeca2023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Caramel L5N1OCTINOXATE, OXYBENZONEAmway Corpd7cb8e53-a36f-43d1-9918-f5680aafb2c42023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Natural L2N2OCTINOXATE, OXYBENZONEAmway Corp01cd84f5-ecd5-4bc3-bb0c-3d5e8ea8a8f52023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Golden L4N1OCTINOXATE, OXYBENZONEAmway Corpff9c6565-a942-494f-af8c-557974675db82023-10-23WarningsExact identifier
application number: M020
Artistry Youth Xtend Lifting Smoothing Foundation Shade Plush L3C1OCTINOXATE, OXYBENZONEAmway Corp9ca531ae-10b5-4791-b62c-37b99bc1d4ea2023-10-23WarningsExact identifier
application number: M020
g and h Protect BodyENSULIZOLE, OCTISALATE, ZINC OXIDEAccess Business Group LLC03768ff4-0c67-48b3-a2f3-321d0a6790e82023-10-23WarningsExact identifier
application number: M020
Artistry Skin Nutrition Multi-Defense UV ProtectZINC OXIDE, TITANIUM DIOXIDEAccess Business Group LLC82623c46-9ec3-4331-a2db-9b8d07fa18172023-10-23WarningsExact identifier
application number: M020
Coconut SPF 15 Broad Spectrum Lip BalmCOCONUT SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca75d28eb-2f41-7146-e053-2a95a90a86722023-10-23WarningsExact identifier
application number: M020
Bubblegum SPF 15 Broad Spectrum Lip BalmBUBBLEGUM SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca7590383-661f-5b1e-e053-2995a90a197e2023-10-23WarningsExact identifier
application number: M020
Blackberry Smoothie SPF 15 Broad Spectrum Lip BalmBLACKBERRY SMOOTHIE SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca7577d5f-69d8-3f32-e053-2995a90aaba52023-10-23WarningsExact identifier
application number: M020
Breath Fresh SPF 15 Broad Spectrum Lip BalmBREATH FRESH SPF 15 BROAD SPECTRUM LIP BALMRaining Rose, Inca0c3a62f-5c11-c78c-e053-2a95a90a3a582023-10-23WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83249-020-01832490020011 TUBE in 1 CARTON (83249-020-01) / 11.5 mL in 1 TUBE1 tube2026-01-13NoNoCurrent