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 223 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Defense Minerals (Deep)ZINC OXIDEEminence Organic Skin Care2e24391f-4982-efae-e063-6394a90accaa2025-03-01WarningsExact identifier
application number: M020
FRUDIA Blueberry Hydrating Air Fit SunscreenOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEWELCOS CO.,LTD.8b2a1baa-e528-48d6-9cd8-c3cb55e0641b2025-02-28WarningsExact identifier
application number: M020
BRUSH ON BLOCK SPF 50 MINERALZINC OXIDESPF Ventures, LLC2f1b5454-8bf5-b447-e063-6394a90a743a2025-02-27WarningsExact identifier
application number: M020
Clear Defense SPF 45ZINC OXIDE, OCTINOXATEPrivate Label Skin Cared681d92f-3501-4fca-b629-096341f20ab12025-02-27WarningsExact identifier
application number: M020
HA Physical Tint SPF 44ZINC OXIDE, TITANIUM DIOXIDEPrivate Label Skin Carea5e19d77-703e-41e0-9a02-19227dc6c8192025-02-27WarningsExact identifier
application number: M020
Physical Daily Defense Broad Spectrum Sunscreen SPF 40ZINC OXIDEPrivate Label Skin Care18444581-66a4-4eda-a8df-627fa3b4b98a2025-02-26WarningsExact identifier
application number: M020
BRUSH ON BLOCK SPF 50 MINERAL TRANSLUCENT ZINC ONLY REFILLZINC OXIDE/TITANIUM DIOXIDESPF Ventures, LLC2f069114-9ca8-aed4-e063-6394a90a46d82025-02-26WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Cream230 NMelaleuca Inc.2f133abb-cad2-2ac8-e063-6294a90aa4802025-02-26WarningsExact identifier
application number: M020
BRUSH ON BLOCK SPF 50 KIDS MINERALZINC OXIDESPF Ventures, LLC2f17b5fe-44da-964b-e063-6394a90ae6992025-02-26WarningsExact identifier
application number: M020
Sun Defense Minerals (Tan)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2efb73a6-601d-61a4-e063-6294a90af8252025-02-25WarningsExact identifier
application number: M020
Rida Hair Research InstituteAVOBENZONE,OCTISALATE,OCTOCRYLENERida LLCece9dfd8-5f40-49b4-a97e-d4e6ffdb1dca2025-02-25WarningsExact identifier
application number: M020
COOLA Classic Body SPF 70 Peach BlossomAVOBENZONE, OCTISALATE, OCTOCRYLENECOOLA, LLCed217698-f552-677e-e053-2995a90acb0a2025-02-25WarningsExact identifier
application number: M020
COOLA Classic Body SPF 30 Tropical CoconutAVOBENZONE, OCTISALATE, OCTOCRYLENECOOLA, LLCed0f8249-aba8-b67c-e053-2a95a90af7eb2025-02-25WarningsExact identifier
application number: M020
Hydro Essence Broad Spectrum Sunscreen SPF 40ZINC OXIDE, OCTINOXATEPrivate Label Skin Caref176c1b1-f539-417f-98b5-69d99365f2f22025-02-25WarningsExact identifier
application number: M020
Sun Defense Minerals (Tan)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2ee82379-6609-fd8e-e063-6294a90acf6c2025-02-24WarningsExact identifier
application number: M020
Vacation SPF 50 ClassicAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVacation Inc.f2780cb5-063c-10d3-e053-2995a90a85762025-02-24WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC2ee9b3dc-91cd-1af9-e063-6394a90a78e12025-02-24WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC2edc79f8-aac5-15eb-e063-6394a90a97362025-02-23WarningsExact identifier
application number: M020
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 AVELLANA 270-COCTINOXATE, ZINC OXIDEBEL STAR S Adc25651b-0e30-c325-e053-2995a90a809e2025-02-21WarningsExact identifier
application number: M020
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 AZUCAR BLANCA 110-COCTINOXATE, ZINC OXIDEBEL STAR S Adc129cd6-a173-d2b3-e053-2a95a90aa04e2025-02-21WarningsExact 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