FDA.reportPublic FDA data

dr. brandt SUN SHIELD SPF 50

Product NDC
81568-101
11-digit product format
815680101
Labeler code
81568
Product ID
81568-101_d6922659-fdc4-48c0-a7d6-a3051be051c1
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LIQUID
Route
TOPICAL
Labeler
Dr. Brandt
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-02-15
Substance
ZINC OXIDE
Active strength
17 g/100mL
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
dr. brandt SUN SHIELD SPF 50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE17 g/100mL

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
6f8af59b-d423-4250-8ddc-061fea886e3eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
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
81568-101-50dr. brandt SUN SHIELD SPF 5050 mL in 1 BOTTLE, DROPPERLIQUID502
81568-101-50dr. brandt SUN SHIELD SPF 501 in 1 BOXLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81568-101DR. BRANDT SUN SHIELD SPF 50 (ZINC OXIDE) LIQUID [DR. BRANDT]2Current NDC, Legacy NDC, 2 package rows20240907_6f8af59b-d423-4250-8ddc-061fea886e3e.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 39 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDRA SPF 34HOMOSALATE, OCTYL SALICYLATE, AVOBENZONEDrmtlgy, LLC31e41ed5-8498-4e2d-928a-c15ca99775e42026-04-21WarningsExact identifier
application number: M020
FORGESKINMINERAL TALLOW SUNSCREENGUANGZHOU KANGLIXIN BIOTECHNOLOGY CO.,LTD4fe913f4-b0be-dc53-e063-6294a90a363c2026-04-20WarningsExact identifier
application number: M020
ROUND LAB BIRCH JUICE MOISTURIZING UVLOCK SUNSCREEN SPF50 BROAD SPECTRUMAVOBENZONE, HOMOSALATE, OCTISALATESEORIN COMPANY Co., Ltd.228dcd68-aaba-0451-e063-6394a90a8ad02026-04-20WarningsExact identifier
application number: M020
Biore Aqua Rich UVOCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATEKAO USAf900db18-5fe2-1d74-e053-6394a90a3ca22026-04-20WarningsExact identifier
application number: M020
Biore UV Aqua RichOCTOCRYLENE, OCTISALATE, AVOBENZENE, HOMOSALATEKAO USA2bc23bb5-86bb-7915-e063-6394a90a9d722026-04-20WarningsExact identifier
application number: M020
ETUDE SunPrise Mild Airy Finish SunstickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEETUDE CORPORATION25abc744-5b62-acb4-e063-6394a90af1102026-04-19WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c7c399-b05e-2545-e053-2995a90ac6112026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c7c399-b060-2545-e053-2995a90ac6112026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c7d9f4-986f-70f7-e053-2a95a90a4f8a2026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c81845-afcb-18ac-e053-2a95a90abdbe2026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c83245-a40c-8f05-e053-2a95a90a05212026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c84047-fd3b-ea66-e053-2a95a90ae9aa2026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c623aa-3846-b7f4-e053-2995a90aecb52026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c585ff-88de-e29c-e053-2a95a90af4d42026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c852de-4c36-6d93-e053-2995a90aff612026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c86288-bb22-03b1-e053-2995a90a31612026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c8742f-1060-48bc-e053-2995a90a31c22026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c4eedc-12a0-6418-e053-2a95a90a55e72026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c8849a-6624-6987-e053-2a95a90a45462026-04-18WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c8ac70-a8c8-2f07-e053-2a95a90a3d012026-04-18WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
81568-101-50815680101501 BOTTLE, DROPPER in 1 BOX (81568-101-50) / 50 mL in 1 BOTTLE, DROPPER2021-02-150000-00-00NoNoCurrent