FDA.reportPublic FDA data

MDP UV BIO SUNSCREEN

Product NDC
72220-003
11-digit product format
722200003
Labeler code
72220
Product ID
72220-003_30877734-91d7-34c8-e063-6294a90a0e64
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
Dosage form
CREAM
Route
TOPICAL
Labeler
SKINIDEA CO., LTD
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-01
Substance
ZINC OXIDE; HOMOSALATE; OCTOCRYLENE; OCTISALATE
Active strength
103.8; 60; 50; 45 mg/mL; mg/mL; mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
MDP UV BIO SUNSCREEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE103.8 mg/mL
HOMOSALATE60 mg/mL
OCTOCRYLENE50 mg/mL
OCTISALATE45 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3087771e-2ab8-2198-e063-6294a90a37d4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72220-003-01MDP UV BIO SUNSCREEN40 mL in 1 TUBECREAM401
72220-003-02MDP UV BIO SUNSCREEN1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72220-003MDP UV BIO SUNSCREEN (ZINC OXIDE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) CREAM [SKINIDEA CO., LTD]1Current NDC, 2 package rows20250319_3087771e-2ab8-2198-e063-6294a90a37d4.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 227 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EMMA LEWISHAM Sunceutical SPF 50 Mineral Glow SerumZINC OXIDE 20%EMMA LEWISHAM US, INC.2b097709-913f-d906-e063-6394a90a04462025-02-05WarningsExact identifier
application number: M020
EMMA LEWISHAM Sunceutical SPF 50 Mineral Face CreamZINC OXIDE 20%EMMA LEWISHAM US, INC.2c703df8-23af-d630-e063-6294a90a1a242025-02-05WarningsExact identifier
application number: M020
doTERRA SunZINC OXIDEdoTERRA International, LLCdd308fef-e312-4ced-e053-2995a90a76fd2025-02-05WarningsExact identifier
application number: M020
OrgaPlus Ultra Pure Sun EX 15gOCTINOXATE, OCTISALATE, OCTOCRYLENEBLUEZONWIDE CO.,LTDb686ef63-7eee-4a4d-a559-417d8b09cc4f2025-02-05WarningsExact identifier
application number: M020
OrgaPlus Ultra Pure Sun EX 22gOCTINOXATE, OCTISALATE, OCTOCRYLENEBLUEZONWIDE CO.,LTDd3c422f6-a83d-48fc-94fc-2749666426c82025-02-05WarningsExact identifier
application number: M020
EMMA LEWISHAM Sunceutical SPF 50 Mineral Body CreamZINC OXIDE 20%EMMA LEWISHAM US, INC.2d65b2d0-7013-d0ad-e063-6394a90ad4c22025-02-05WarningsExact identifier
application number: M020
Olay Sun Hydrating Facial Moisturizer with Sunscreen SPF 30 Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEThe Procter & Gamble Manufacturing Company2d6a6fed-a26e-e3a6-e063-6394a90ae2c72025-02-05WarningsExact identifier
application number: M020
Brush On Block Sheer Genius SPF 50 Mineral MoistureZINC OXIDESPF Ventures, LLC2d4b8c92-b932-89a7-e063-6394a90a621d2025-02-04WarningsExact identifier
application number: M020
Seven Thirty Daily Habit Broad Spectrum SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESAN DIEGO NATURAL SOAP COMPANY30ca8f9d-b6a5-4af0-9d7b-487212e40e632025-02-03WarningsExact identifier
application number: M020
Atlanta Acne Specialist Everyday Sunscreen SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESAN DIEGO NATURAL SOAP COMPANY3057f8ad-5850-49a0-b44d-3a1da84126e32025-02-03WarningsExact identifier
application number: M020
TiZO Ultra Zinc SPF 40 (Tinted)ZINC OXIDEFallien Cosmeceuticals, LTD.2d3faa43-0d78-58de-e063-6294a90a0b172025-02-03WarningsExact identifier
application number: M020
TiZO Eye Renewal SPF 20 (Non-Tinted)ZINC OXIDEFallien Cosmeceuticals, LTD2d40099a-2cfa-1d99-e063-6394a90a36a62025-02-03WarningsExact identifier
application number: M020
Brush On Block SPF 30 Mineral Powder Translucent Zinc Only-RefillZINC OXIDESPF Ventures, LLC2d47eb76-e644-4e04-e063-6294a90a93cc2025-02-03WarningsExact identifier
application number: M020
Brush On Block Sun Shine SPF 30 Protective Lip Oil Peony TintTITANIUM DIOXIDE/ZINC OXIDESPF Ventures LLC2d490531-af36-87d0-e063-6394a90acf492025-02-03WarningsExact identifier
application number: M020
YOUR TINTED MOISTURIZER HYDRATING ANTI AGING BROAD SPECTRUM SPF 30OCTISALATE, OCTINOXATE, OXYBENZONE, AVOBENZONESkin Ai, LLC2d8b7d07-2249-898b-e063-6394a90af6ad2025-02-01WarningsExact identifier
application number: M020
ESSENCE LIGHT SUNSCREEN SPF 50 PAAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEENGLEWOOD LAB, INC.f5c79f1a-cecd-2409-e053-2995a90ad06f2025-01-31WarningsExact identifier
application number: M020
RODAN - FIELDS ESSENTIALS Body Sunscreen BROAD SPECTRUM SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERodan & Fields67b55df8-9623-4352-b136-b0bc8d1efe022025-01-31WarningsExact identifier
application number: M020
Oil-Free Daily Hydration SPF 15OCTINOXATE, AVOBENZONEBoscia LLCec322ae5-ab03-4c7b-9c6d-0bda3327c72a2025-01-31WarningsExact identifier
application number: M020
PAULAS CHOICE HYDRALIGHT SHINE-FREE DAILY MINERAL COMPLEX Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEPaula's Choice, Incb90658d0-e422-4265-a6ee-39c29b6c116a2025-01-31WarningsExact identifier
application number: M020
SunStation USA SPF-30 SPORT SUNSCREENZINC OXIDERENU LABORATORIES, LLC11d3c60e-238d-999e-e063-6394a90a624b2025-01-31WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72220-003-017222000030140 mL in 1 TUBE40 mlHistorical
72220-003-02722200003021 TUBE in 1 CARTON (72220-003-02) / 40 mL in 1 TUBE (72220-003-01) 1 tube2025-03-01NoNoCurrent