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 206 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kiehls Dermatologist Solutions Better Screen UV Serum Broad Spectrum SPF 50 Plus SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc48980ef3-ebda-450e-9f15-effad27dec9a2025-07-11WarningsExact identifier
application number: M020
KLARINA Sheer Mineral Sunscreen Blender SPF 50ZINC OXIDEKLARINA INC081941e3-02da-43a2-bf6f-a6d0f053272f2025-07-10WarningsExact identifier
application number: M020
ATHLETIC COSMETIC COMPANY Clear Power Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEATHLETIC COSMETIC COMPANY LLCf143a8e0-b32b-4b14-a6ae-f013627b484c2025-07-10WarningsExact identifier
application number: M020
Venofye Orchard Bee Brilliance SPF 30OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONEInnovation Brands Inc.7c36c7e5-bc0b-40e6-bdbc-fd34f0b0eafe2025-07-10WarningsExact identifier
application number: M020
Touch Anti-Aging SPF 30 MoisturizerZINC OXIDE, OCTINOXATE, AND OCTISALATEDiractions Capital LLC47ce948e-5848-43a1-880e-aeb78e9ad1b32025-07-10WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 60 Breakout Free Oil Free Face Dry Touch Broad Spectrum SPF 60 Sunscreen Water Resistant 80 MinutesAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc06f2ced8-273e-454f-92b4-2846f6674b372025-07-10WarningsExact identifier
application number: M020
SPF30 unseen sunscreen 01BUTYL METHOXYDIBENZOYLMETH, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENECosmuses Cosmetics (Ningbo) Co., Ltd.398bb1f5-80ea-c589-e063-6294a90abefd2025-07-09WarningsExact identifier
application number: M020
Prada Reveal Skin Optimizing Foundation Broad Spectrum SPF 17 SunscreenENSULIZOLESICOS ET CIE1ac50772-0bea-4a41-8300-03f65f0bed522025-07-09WarningsExact identifier
application number: M020
Prada Reveal Skin Optimizing Foundation Broad Spectrum SPF 17 SunscreenENSULIZOLEL'Oreal USA Products Ince74a8c43-ec70-4de1-b2b5-0e89e40bfb402025-07-08WarningsExact identifier
application number: M020
IT COSMETICS HELLO SUNSHINE INVISIBLE HYDRATING SERUM BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEL'Oreal USA Products Inc.84fbbb01-bb16-41a6-a53a-6e85d515ca2c2025-07-08WarningsExact identifier
application number: M020
CeraVe Developed with Dermatologists Hydrating Sheer Sunscreen Broad Spectrum SPF 30 Face and Body Water Resistant 80 Minutes Hybrid FormulaHOMOSALATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDEL'Oreal USA Products, Inc.cd69df67-5231-4a75-a9fb-a8669806a8922025-07-08WarningsExact identifier
application number: M020
Neutrogena Beach Defense Kids Sunscreen SPF 60 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLCfea50c84-0567-8547-e053-6394a90aafb72025-07-07WarningsExact identifier
application number: M020
24K Skin Tone Moisturizer SPF 30OCTINOXATE, HOMOSALATE, OCTISILATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.b4f37f69-c61d-40c6-86cc-95d041b4d1b52025-07-07WarningsExact identifier
application number: M020
Vine Vera Resveratrol Cabernet Replenishing MoistureOCTINOXATE, HOMOSALATE, OCTISILATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.c48a7346-3971-4946-b527-a5549a98e2462025-07-07WarningsExact identifier
application number: M020
Lavelier Divine Day Defense Broad Spectrum SPF 30OCTINOXATE, HOMOSALATE, OCTISILATE, OXYBENZONE AND AVOBENZONEInnovation Brands Inc.1f33a93f-ae3f-4024-9d23-26b01eed17642025-07-03WarningsExact identifier
application number: M020
HIGHHEAT Sunscreen SPF 50 Performance For AthletesAVOBENZONE, OCTISALATE, OCTOCRYLENEDUGOUT ESSENTIALS LLC3b7cddb5-00d2-4998-8eec-5e5a7c5a60972025-07-03WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDECAPE COD SKIN CARE CO. INC.39093b2d-3fbb-8378-e063-6294a90ac6d82025-07-03Exact identifier
application number: M020
Neutrogena Clear Face Serum Sunscreen Broad Spectrum SPF 60AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKenvue Brands LLC09ccb37b-78ee-b510-e063-6294a90a48d52025-07-01WarningsExact identifier
application number: M020
First Aid Beauty FAB Ultra Light Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDEPort Jervis Laboratories, Inc.4b442fdf-a9cf-7e5a-e063-6394a90a9e1e2025-07-01WarningsExact identifier
application number: M020
Sincerely Yours Sunny Side Up Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDESincerely Yours Inc.4c9dfa22-70f7-83f6-e063-6394a90aa8c52025-07-01WarningsExact 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