FDA.reportPublic FDA data

Vaihea Protect Clean SPF Drops

Product NDC
83395-050
11-digit product format
833950050
Labeler code
83395
Product ID
83395-050_42f4881e-6356-9a8a-e063-6294a90af435
Type
HUMAN OTC DRUG
Nonproprietary name
Zinc Oxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Vaihea Skincare LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-31
Substance
ZINC OXIDE
Active strength
132 mg/mL
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
Vaihea Protect Clean SPF Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE132 mg/mL

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
fe7e3145-a8e2-d14f-e053-6394a90abb5eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83395-050-01Vaihea Protect Clean SPF Drops50 mL in 1 BOTTLE, DROPPERLOTION504
83395-050-02Vaihea Protect Clean SPF Drops1 in 1 CARTONLOTION14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83395-050VAIHEA PROTECT CLEAN SPF DROPS (ZINC OXIDE) LOTION [VAIHEA SKINCARE LLC]2Current NDC, 2 package rows20241027_fe7e3145-a8e2-d14f-e053-6394a90abb5e.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 148 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral SPF 40, TintedTITANIUM DIOXIDE, ZINC OXIDEAcne Specialists LLC2fb14c4f-a435-aa6e-e063-6394a90a7d8d2025-12-08WarningsExact identifier
application number: M020
Mineral Sunscreen SPF 40 Non-TintedTITANIUM DIOXIDE, ZINC OXIDESkin Restoration Aesthetics2fc4f701-eea2-7913-e063-6294a90a86932025-12-08WarningsExact identifier
application number: M020
Mineral Sunscreen SPF 40 TintedTITANIUM DIOXIDE, ZINC OXIDESkin Restoration Aesthetics2fc55e8c-41d6-15cc-e063-6394a90ac5432025-12-08WarningsExact identifier
application number: M020
Zinc Oxide SPF 40 TintedZINC OXIDESkin Restoration Aesthetics2fc60a39-789b-3d11-e063-6294a90a9abf2025-12-08WarningsExact identifier
application number: M020
Zinc Oxide SPF 40 Non-TintedZINC OXIDESkin Restoration Aesthetics2fc68041-acfe-8db6-e063-6294a90ad8ba2025-12-08WarningsExact identifier
application number: M020
Daily Tinted Mineral SPFTITANIUM DIOXIDE, ZINC OXIDESkin Restoration Aesthetics2fc6e168-b2c1-bf9d-e063-6394a90aade72025-12-08WarningsExact identifier
application number: M020
Ultra Solar Shield non-tinted moisturizing mineral SPF 40ZINC OXIDEJoyce Kelly Enterprises365bdf7a-c034-beef-e063-6394a90a4dd72025-12-08Exact identifier
application number: M020
UV Shade tinted matte mineral SPF 40TITANIUM DIOXIDE, ZINC OXIDEJoyce Kelly Enterprises365b3a1e-8410-da06-e063-6294a90a462f2025-12-08Exact identifier
application number: M020
Solar Shield non-tinted matte mineral SPF 40TITANIUM DIOXIDE, ZINC OXIDEJoyce Kelly Enterprises365b68a0-0f89-0f43-e063-6294a90a5eee2025-12-08Exact identifier
application number: M020
Ultra UV Shade tinted moisturizing mineral SPF 40ZINC OXIDEJoyce Kelly Enterprises365ba78a-b7df-a31f-e063-6394a90a16732025-12-08Exact identifier
application number: M020
Mineral Sunscreen tintedTITANIUM DIOXIDE, ZINC OXIDEFace 5, LLC3000a0a7-2b51-b832-e063-6294a90a4a082025-12-08WarningsExact identifier
application number: M020
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFace 5, LLC3001028b-bb36-04ec-e063-6294a90a1e492025-12-08WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFace 5, LLC3001aa3a-cc8b-6ad4-e063-6394a90a223f2025-12-08WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFace 5, LLC300268ff-f9ef-1006-e063-6294a90a5fdf2025-12-08WarningsExact identifier
application number: M020
Illuminating Daily SPF 40 Lightly TintedZINC OXIDEFace 5, LLC3001ef4f-4cbb-8931-e063-6394a90a5cef2025-12-08WarningsExact identifier
application number: M020
Illuminating Daily SPF40 Non-TintedZINC OXIDEFace 5, LLC300218c9-65cf-d984-e063-6294a90a15172025-12-08WarningsExact identifier
application number: M020
Illuminating Daily SPF 40 Lightly TintedZINC OXIDEFace 5, LLC300303e7-ef89-7449-e063-6294a90ac8112025-12-08WarningsExact identifier
application number: M020
Clear Path Tinted Facial SunscreenTITANIUM DIOXIDE, ZINC OXIDELULUS SPA BOUTIQUE37657755-fa82-88a0-e063-6394a90ade472025-12-08Exact identifier
application number: M020
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEDermacare376468ce-8d9b-b672-e063-6294a90a0bd12025-12-08Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDermacare37643884-f186-fb54-e063-6394a90a450f2025-12-08Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83395-050-018339500500150 mL in 1 BOTTLE, DROPPER50 mlHistorical
83395-050-02833950050021 BOTTLE, DROPPER in 1 CARTON (83395-050-02) / 50 mL in 1 BOTTLE, DROPPER (83395-050-01) 2023-08-31NoNoCurrent