FDA.reportPublic FDA data

Ultra sheer mineral sunscreen PRO SPF30

Product NDC
72113-112
11-digit product format
721130112
Labeler code
72113
Product ID
72113-112_2ce06566-2eb1-9a00-e063-6394a90a9ba9
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Eden Brands Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-18
Substance
ZINC OXIDE
Active strength
188 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
Ultra sheer mineral sunscreen PRO SPF30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE188 mg/g

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
2ce06566-2eb0-9a00-e063-6394a90a9ba9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72113-112-14Ultra sheer mineral sunscreen PRO SPF301 in 1 CARTONLOTION11
72113-112-14Ultra sheer mineral sunscreen PRO SPF3060 g in 1 BOTTLELOTION601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72113-112ULTRA SHEER MINERAL SUNSCREEN PRO SPF30 (ZINC OXIDE) LOTION [EDEN BRANDS INC.]1Current NDC, 2 package rows20250216_2ce06566-2eb0-9a00-e063-6394a90a9ba9.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 121 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bio H Plus Daily Defense And RevitalizeZINC OXIDEBIOHEALTH PLUS LLC3765331e-ad4b-5661-e063-6294a90a7c202025-12-15Exact identifier
application number: M020
Facial Mineral FusionTITANIUM DIOXIDE, ZINC OXIDEIT INTELLIGENT TREATMENT LLC35944621-e6fb-cd98-e063-6294a90aa6412025-12-15Exact identifier
application number: M020
Face LoveZINC OXIDECLARITY SKIN CARE STUDIO, INC.35d043a7-7269-469f-e063-6294a90a1a4d2025-12-15Exact identifier
application number: M020
Mineral MousseTITANIUM DIOXIDE, ZINC OXIDECLARITY SKIN CARE STUDIO, INC.35d00778-3857-ce8f-e063-6394a90ab3752025-12-15Exact identifier
application number: M020
Chem-Free Sunscreen Non-Tinted FormulaZINC OXIDEIT INTELLIGENT TREATMENT LLC3594d573-c680-62c9-e063-6294a90a42292025-12-15Exact identifier
application number: M020
Chem Free Sunscreen Tinted FormulaZINC OXIDEIT INTELLIGENT TREATMENT LLC35948531-37ef-1fce-e063-6294a90ae79b2025-12-15Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDER. Sonia Batra, MD, Inc.35933039-8beb-9f98-e063-6394a90a60bb2025-12-15Exact identifier
application number: M020
Simply Protected Tinted Mineral SunscreenZINC OXIDEHealthy Skin & Body LLC380416b9-180a-3904-e063-6294a90a7bee2025-12-15Exact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDER. Sonia Batra, MD, Inc.3592edca-cab0-6c44-e063-6294a90a17272025-12-15Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHealthy Skin & Body LLC38046e71-f171-7e96-e063-6294a90a1f0b2025-12-15Exact identifier
application number: M020
Barrier Plus Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHealthy Skin & Body LLC38038beb-d0f0-ced2-e063-6294a90ac4232025-12-15Exact identifier
application number: M020
Extreme Protection Non TintedZINC OXIDEBIOHEALTH PLUS LLC3764cbeb-55f5-4a9c-e063-6394a90a863d2025-12-15Exact identifier
application number: M020
Happy Mineral Sunscreen Primer SPFTITANIUM DIOXIDE, ZINC OXIDEACNE CLINIC LAS VEGAS BY JUSTINA37d9c5f2-f414-6efa-e063-6294a90a927f2025-12-15Exact identifier
application number: M020
Comfort Mineral Mousse SunscreenTITANIUM DIOXIDE, ZINC OXIDEBIOHEALTH PLUS LLC3765dd17-ffbd-bcf4-e063-6394a90a2c2b2025-12-15Exact identifier
application number: M020
Prime And Protect DewyZINC OXIDEKalon Skin Studio, LLC3593cefe-a08f-eb88-e063-6394a90aaff62025-12-15Exact identifier
application number: M020
GlowZINC OXIDEGODDESSLYNNEBODYANDSKIN37247365-33ee-563d-e063-6394a90a249e2025-12-15Exact identifier
application number: M020
Prime And Protect MatteTITANIUM DIOXIDE, ZINC OXIDEKalon Skin Studio, LLC35939630-1166-1c70-e063-6294a90aac6b2025-12-15Exact identifier
application number: M020
Non-Tinted 20% Zinc Mineral SunscreenZINC OXIDEBELLA MEDICAL SKIN CARE36d9d83b-7da5-a006-e063-6394a90a9d842025-12-15Exact identifier
application number: M020
Non-Tinted 20% Zinc Mineral SunscreenZINC OXIDEBELLA MEDICAL SKIN CARE36da1a55-c076-cdd9-e063-6294a90ac97c2025-12-15Exact identifier
application number: M020
Tinted Lip BalmTITANIUM DIOXIDE, ZINC OXIDEGoldberg, Howard S MD Inc3598205d-2e87-9292-e063-6294a90a1f2a2025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72113-112-14721130112141 BOTTLE in 1 CARTON (72113-112-14) / 60 g in 1 BOTTLE1 bottle2024-12-18NoNoCurrent