FDA.reportPublic FDA data

Essential Mineral Sun Protection

Product NDC
85387-258
11-digit product format
853870258
Labeler code
85387
Product ID
85387-258_45b370ec-f575-b104-e063-6294a90a105b
Type
HUMAN OTC DRUG
Nonproprietary name
Titanium Dioxide, Zinc Oxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Fern Burg
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-13
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
100; 30 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Essential Mineral Sun Protection
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE100 mg/g
ZINC OXIDE30 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
15FIX9V2JPInternal UNII lookup
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
34a360b2-6798-c7e8-e063-6294a90a5cbbAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85387-258-50Essential Mineral Sun Protection53 g in 1 BOTTLE, PUMPCREAM532

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85387-258ESSENTIAL MINERAL SUN PROTECTION (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FERN BURG]1Current NDC, 1 package rows20250510_34a360b2-6798-c7e8-e063-6294a90a5cbb.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 123 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Non Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEVIDA HEALTH & WELLNESS LLC3724cb53-0198-c604-e063-6294a90aa64b2025-12-15Exact identifier
application number: M020
Untinted Sheer DefenseTITANIUM DIOXIDE, ZINC OXIDEKristina Lerner35be50b7-a9af-29ee-e063-6394a90a45ba2025-12-15Exact identifier
application number: M020
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEVIDA HEALTH & WELLNESS LLC3724ea3c-b018-c125-e063-6394a90a01f12025-12-15Exact identifier
application number: M020
Tinted SunscreenTITANIUM DIOXIDE, ZINC OXIDEVIDA HEALTH & WELLNESS LLC37252429-d692-c05a-e063-6294a90a6af62025-12-15Exact identifier
application number: M020
Parasol Daily Mineral SunscreenZINC OXIDEBodi & Wax, LLC35d2fbeb-935b-f0a9-e063-6294a90acd792025-12-15Exact identifier
application number: M020
BHSkin Sheer Tinted Zinc and Titanium SPF 40TITANIUM DIOXIDE, ZINC OXIDEDon Mehrabi, M.D. A Professional Medical Corporation423c7e62-ad50-0dc3-e063-6294a90ad05a2025-12-15WarningsExact identifier
application number: M020
Tined Mineral Sunscreen Whipped MousseTITANIUM DIOXIDE, ZINC OXIDEESTILO SALON & SPA LLC3699c107-d063-cc6f-e063-6394a90a6ad42025-12-15Exact identifier
application number: M020
BHSkin Sheer Tinted Zinc and Titanium SPF 40TITANIUM DIOXIDE, ZINC OXIDEDon Mehrabi, M.D. A Professional Medical Corporation44776529-3aa6-4fa3-b2ce-f624c4cf41bd2025-12-15WarningsExact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDEJMSE Management, LLC36ec860f-2066-196c-e063-6294a90a21212025-12-15Exact identifier
application number: M020
Parasol Daily Mineral SunscreenZINC OXIDEBodi & Wax, LLC35d3262a-1d8d-2afa-e063-6294a90afd492025-12-15Exact identifier
application number: M020
Parasol Daily Mineral Sunscreen Non-TintedZINC OXIDEBodi & Wax, LLC35d37c2e-abc0-6bda-e063-6294a90a8fc32025-12-15Exact identifier
application number: M020
Tined Mineral Sunscreen Whipped MousseTITANIUM DIOXIDE, ZINC OXIDEESTILO SALON & SPA LLC36999510-88f0-64fc-e063-6294a90a3d092025-12-15Exact identifier
application number: M020
Parasol Daily Mineral Sunscreen Non-TintedZINC OXIDEBodi & Wax, LLC35d3486c-c6e8-4d31-e063-6294a90a12192025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen CreamZINC OXIDEESTILO SALON & SPA LLC3699f6df-63b8-f255-e063-6394a90af2c42025-12-15Exact identifier
application number: M020
Tinted Mineral Sunscreen CreamZINC OXIDEESTILO SALON & SPA LLC369a5997-7dbe-254d-e063-6394a90a5bef2025-12-15Exact identifier
application number: M020
Non Tinted Mineral Sunscreen 20Percent Zinc OxideZINC OXIDEESTILO SALON & SPA LLC369a8a99-c755-3c7f-e063-6394a90ac16c2025-12-15Exact identifier
application number: M020
Non Tinted Mineral Sunscreen 20Percent Zinc OxideZINC OXIDEESTILO SALON & SPA LLC369abc9d-9c20-5397-e063-6394a90a17232025-12-15Exact identifier
application number: M020
Sunshade Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37dec631-fdaf-fbdf-e063-6394a90a6c2b2025-12-15Exact identifier
application number: M020
Matte Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEEDIT EUROSPA, LLC37527317-0f10-d7e6-e063-6394a90a35a62025-12-15Exact identifier
application number: M020
Sunshade Mineral Stick SunscreenTITANIUM DIOXIDE, ZINC OXIDEBELLAGENA SKINCARE STUDIO & SPA37ee31be-bfda-f052-e063-6294a90ac0bb2025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85387-258-508538702585053 g in 1 BOTTLE, PUMP (85387-258-50) 53 g2023-06-13NoNoCurrent