FDA.reportPublic FDA data

Zealios Mineral SPF 30 Sunscreen

Product NDC
83326-004
11-digit product format
833260004
Labeler code
83326
Product ID
83326-004_b82760d4-36f1-436d-b44b-db6081176c37
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Personal Best Products Inc. dba Zealios
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-01
Substance
ZINC OXIDE
Active strength
17600 mg/1
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
Zealios Mineral SPF 30 Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE17600 mg/1

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
c421b00c-6536-4455-81f6-01686f8c2388Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83326-004-03Zealios Mineral SPF 30 Sunscreen1 in 1 TUBECREAM11
83326-004-32Zealios Mineral SPF 30 Sunscreen1 in 1 BOTTLE, PUMPCREAM11

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 3 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunski Hot Block Mineral Sunscreen Stick SPF 50ZINC OXIDEStewart Charley Ventures LLC dba Sunski04ecc5e7-0d9e-4bc7-b964-4cbcc6ed06a82026-09-01WarningsExact identifier
application number: M020
Sun Wave Anti Aging Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC7e48a3d2-e453-4733-b42b-8bea804cda592026-09-01WarningsExact identifier
application number: M020
Sun Wave Anti Aging Lite SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC7204c24f-aab6-45eb-9bd4-879f715ba0752026-09-01WarningsExact identifier
application number: M020
Sun Wave Anti Aging Lite SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC7c1e780a-1831-4f49-a92e-e36017d241a22026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLCd45614c8-b09c-417b-b691-082ea21498802026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC999b0b17-be73-4d42-b182-ce038f4933012026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLCadffff46-4cfb-4c0a-b1a6-75220ee193a52026-09-01WarningsExact identifier
application number: M020
Sun Wave Cross Sport Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC13b2b45b-70e1-46ff-8555-48e1fe98c6512026-09-01WarningsExact identifier
application number: M020
Sun Wave Kids Insta Dry SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Life Brands, LLC5c2a5ca3-e9eb-48ba-8698-592d2c7aa2412026-09-01WarningsExact identifier
application number: M020
Sunceutical SPF 50 Mineral Face CreamZINC OXIDEBaxter Laboratories Pty. Ltd.2c408728-a1de-d51e-e063-6294a90ade0b2026-08-31WarningsExact identifier
application number: M020
SKIN1004 MADAGASCAR CENTELLA HYALU-CICA WATER-FIT SUN SERUM UVBUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENECraver Corporation38d8c1c9-86b5-1edd-e063-6394a90aeb472026-08-30WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGELAVOBENZONE, HOMOSALATE, OCTISALATEISNTREE Inc.5a3a17ff-a7fd-f707-e063-6394a90a31822026-08-29WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID NATURAL SUNCREAMZINC OXIDEISNTREE Inc.5a3a59b2-18b6-521b-e063-6294a90a29582026-08-29WarningsExact identifier
application number: M020
Cetaphil Daily Facial Moisturizer with suncreen SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGalderma Laboratories, L.P.f5eb347f-0d46-4de6-8f3f-9010327678ed2026-08-28WarningsExact identifier
application number: M020
Utu Broad Spectrum SPF 30 Moisturizing Body SunscreenZINC OXIDEUtu Co59938ace-c97c-d758-e063-6394a90a77e42026-08-28WarningsExact identifier
application number: M020
Utu Broad Spectrum SPF 30 Moisturizing Face Mineral Zinc Oxide Sunscreen UnscentedZINC OXIDEUtu Co5982e790-7cdb-c96c-e063-6394a90a02d42026-08-28WarningsExact identifier
application number: M020
Utu Hydrating Sun Balm Broad Spectrum SPF 50ZINC OXIDEUtu Co59d1d0ac-2444-d6f9-e063-6294a90ae80c2026-08-28WarningsExact identifier
application number: M020
Hello Bello Mineral Sunscreen SPF 50ZINC OXIDETopiderm, Inc.54f12764-5c37-4a05-bf96-209fedb93fd12026-08-28WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGELAVOBENZONE, HOMOSALATE, OCTISALATEISNTREE Inc.5a02c540-5b3b-9379-e063-6294a90a00f62026-08-27WarningsExact identifier
application number: M020
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83326-004-03833260004031 CREAM in 1 TUBE (83326-004-03) 1 cream2024-06-01NoNoCurrent
83326-004-32833260004321 CREAM in 1 BOTTLE, PUMP (83326-004-32) 1 cream2024-06-01NoNoCurrent