FDA.reportPublic FDA data

RMS REFRESH EYE BRIGHTENER SPF 30 BROAD SPECTRUM SUNSCREEN HUSH

Product NDC
83249-019
11-digit product format
832490019
Labeler code
83249
Product ID
83249-019_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 HUSH
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
83249-019-01RMS REFRESH EYE BRIGHTENER SPF 30 BROAD SPECTRUM SUNSCREEN HUSH11.5 mL in 1 TUBEEMULSION11.51
83249-019-01RMS REFRESH EYE BRIGHTENER SPF 30 BROAD SPECTRUM SUNSCREEN HUSH1 in 1 CARTONEMULSION11

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 169 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Indie Lee Daily PrimerZINC OXIDEAmerica Exchange38e5232b-7daf-7e61-e063-6394a90aa5b02025-11-06WarningsExact identifier
application number: M020
Duette UntintedZINC OXIDESkin Theory Studios3ce24b39-8bb1-1246-e063-6294a90a32d42025-11-06WarningsExact identifier
application number: M020
Duette TintedZINC OXIDESkin Theory Studios3ce1d7cb-b37d-fb9f-e063-6394a90aaef32025-11-06WarningsExact identifier
application number: M020
Truskin Broad Spectrum Mineral Sunscreen Facial Serum with Vitamin C and AloeZINC OXIDEAllure Labs42f3999f-4163-fadc-e063-6294a90aacf32025-11-06WarningsExact identifier
application number: M020
Melan RXZINC OXIDEMelan RXf4bdf20c-b6bc-55f1-e053-2995a90ac3082025-11-06WarningsExact identifier
application number: M020
ESIKA HYDRACOLOR 2 IN 1 SPF 25 (FUCSIA CAUTIVANTE EXOTIC) - PINKOCTINOXATE AND OXYBENZONEVentura Corporation LTDe1eb77f1-d65c-4af8-a7d9-90f10570960f2025-11-06WarningsExact identifier
application number: M020
Ultraceuticals Ultra UV Protective Daily MoisturisingZINC OXIDEUltraceuticalsfc8a5c02-23b4-b4d8-e053-6294a90a55ea2025-11-06WarningsExact identifier
application number: M020
Vaihea Protect Clean SPF DropsZINC OXIDEVaihea Skincare LLCfe7e3145-a8e2-d14f-e053-6394a90abb5e2025-11-06WarningsExact identifier
application number: M020
Refy Skin TrioZINC OXIDERefy3029a690-dbb0-ff15-e063-6394a90abdbe2025-11-06WarningsExact identifier
application number: M020
Stream2Sea Broad Spectrum 20TITANIUM DIOXIDEStream2Sea, LLC1775d07d-6914-6928-e054-00144ff88e882025-11-06WarningsExact identifier
application number: M020
PHYSICAL TINTED MOISTURIZER SPF44ZINC OXIDE, TITANIUM DIOXIDEDrmtlgy, LLC483d0d28-56f3-4b37-af03-0331e1653d732025-11-06WarningsExact identifier
application number: M020
Neutrogena Rapid Wrinkle Repair Retinol Moisturizer Sunscreen Broad Spectrum SPF 30 DayAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCd3ebe2a9-434e-497c-8fed-b5c73c70a58b2025-11-05WarningsExact identifier
application number: M020
Clear Smart Shine Control Sunscreen Broad Spectrum SPF 25AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.a57bcf44-580d-520e-e053-2a95a90a69232025-11-05WarningsExact identifier
application number: M020
Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.865057ce-f617-4232-a60e-e23c120b0a732025-11-05WarningsExact identifier
application number: M020
Revitalize Solar Protection Fluid Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.29b3ee35-e849-4427-a455-37d92c4b995c2025-11-05WarningsExact identifier
application number: M020
Sarah Creal Brilliant Repair ShieldZINC OXIDESarah Creal LLC258ab6f2-f1a7-2d0d-e063-6294a90af34a2025-11-05WarningsExact identifier
application number: M020
Perricone MD Cold Plasma Plus Neck and Chest Broad Spectrum SPF 25TITANIUM DIOXIDETHG Beauty USA LLC23a55301-2277-6e4f-e063-6394a90af1712025-11-05WarningsExact identifier
application number: M020
Sun Bum Face and Body Stick 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC20d9d60d-e0ce-a177-e063-6394a90a162e2025-11-05WarningsExact identifier
application number: M020
Obagi Nu-Derm Fx System Normal-Dry Skin Transformation Complexion Brightening SystemTITANIUM DIOXIDE, ZINC OXIDEObagi Cosmeceuticals LLC4cbf1dc6-78b3-4e51-a53f-2018ac88136a2025-11-04WarningsExact identifier
application number: M020
SUNBEAT PROCARE FPS 50 KIDSHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, ENSULIZOLETecnoglobal, PH7 S.A. DE C.V.42c74ddf-70a3-f2b1-e063-6294a90a91a92025-11-04WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83249-019-01832490019011 TUBE in 1 CARTON (83249-019-01) / 11.5 mL in 1 TUBE1 tube2026-01-13NoNoCurrent