FDA.reportPublic FDA data

TONEfitSUN Ultra Moisturizing Vegan Sunscreen

Product NDC
58544-150
11-digit product format
585440150
Labeler code
58544
Product ID
58544-150_4ec58c23-16b2-03bb-e063-6394a90a46c0
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Dosage form
CREAM
Route
TOPICAL
Labeler
Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-01
Substance
OCTOCRYLENE; AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength
9; 2.7; 13.5; 4.5 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
TONEfitSUN Ultra Moisturizing Vegan Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTOCRYLENE9 g/100mL
AVOBENZONE2.7 g/100mL
HOMOSALATE13.5 g/100mL
OCTISALATE4.5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal 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
4ec58c23-16b1-03bb-e063-6394a90a46c0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58544-150-01TONEfitSUN Ultra Moisturizing Vegan Sunscreen50 mL in 1 CONTAINERCREAM501
58544-150-02TONEfitSUN Ultra Moisturizing Vegan Sunscreen1 in 1 CARTONCREAM11

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 141 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Physical Block SunscreenTITANIUM DIOXIDE, ZINC OXIDETucson Acne Clinic30dc6e23-ecca-ed0b-e063-6294a90a79512025-12-09WarningsExact identifier
application number: M020
Tinted Physical Block SunscreenTITANIUM DIOXIDE, ZINC OXIDETucson Acne Clinic30ddc3d7-76df-3344-e063-6294a90a65ae2025-12-09WarningsExact identifier
application number: M020
Tinted Physical Block SunscreenTITANIUM DIOXIDE, ZINC OXIDETucson Acne Clinic30ddf80c-8496-0f47-e063-6394a90afc182025-12-09WarningsExact identifier
application number: M020
Lightly Tinted Mineral Block SunscreenZINC OXIDETucson Acne Clinic30dfa973-3217-1e18-e063-6294a90a8d412025-12-09WarningsExact identifier
application number: M020
Lightly Tinted Mineral Block SunscreenZINC OXIDETucson Acne Clinic30df0039-4dc1-7355-e063-6394a90ae8002025-12-09WarningsExact identifier
application number: M020
Advanced Lip GuardTITANIUM DIOXIDE, ZINC OXIDEADVANCED DERMATOLOGY32e66ff3-ae1a-4a2a-e063-6294a90a79632025-12-09Exact identifier
application number: M020
Skin Tone Defender 20% Zinc OxideZINC OXIDECali Skin Care LLC308c711d-4c3e-1208-e063-6394a90a9cc22025-12-09WarningsExact identifier
application number: M020
Advanced Light Perfecting SunscreenZINC OXIDEADVANCED DERMATOLOGY32d781ca-7993-9875-e063-6294a90a5c262025-12-09Exact identifier
application number: M020
Advanced Light Perfecting SunscreenZINC OXIDEAdvanced Dermatology32e6c080-6ce3-8d99-e063-6294a90ac1bc2025-12-09Exact identifier
application number: M020
StriVectin multi-action Super-C SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEStriVectin Operating Company, Inc.b299df12-fbdd-437b-9bfa-4846e361725a2025-12-09WarningsExact identifier
application number: M020
Original TintTITANIUM DIOXIDE, ZINC OXIDEL.S. MOORE LLC37f1e019-32c4-b733-e063-6394a90aca282025-12-09Exact identifier
application number: M020
RADIANCEZINC OXIDEL.S. MOORE LLC37f254cb-9de5-8f67-e063-6294a90a4e282025-12-09Exact identifier
application number: M020
StriVectin Advanced Retinol Daily Repair Moisturizer SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEStriVectin Operating Company, Inc.cfbdbba8-a739-fd32-e053-2a95a90a6f312025-12-09WarningsExact identifier
application number: M020
Hint of TintZINC OXIDEL.S. MOORE LLC37f20c14-070e-4f86-e063-6294a90ad4c22025-12-09Exact identifier
application number: M020
Hint of TintZINC OXIDEL.S. MOORE LLC37f330a0-790a-1656-e063-6294a90a691c2025-12-09Exact identifier
application number: M020
Original TintTITANIUM DIOXIDE, ZINC OXIDEL.S. MOORE LLC37f2e363-e85f-f601-e063-6294a90ab1202025-12-09Exact identifier
application number: M020
Original TintTITANIUM DIOXIDE, ZINC OXIDEL MOORE AESTHETICS37f1ac8c-3bfb-10da-e063-6294a90a8ca82025-12-09Exact identifier
application number: M020
RoC Multi Correxion Revive and Glow Moisturizer SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERoC Skincare40d4cfeb-fb00-801e-e063-6394a90ada6b2025-12-09WarningsExact identifier
application number: M020
RADIANCEZINC OXIDEL.S. MOORE LLC37f2b104-0213-c88c-e063-6294a90a42472025-12-09Exact identifier
application number: M020
Mineral Sunscreen Moisturizing Lightly TintedZINC OXIDECutis Wellness Dermatology And Dermatopathology PLLC3350c673-2afd-a00a-e063-6294a90aa1962025-12-09Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58544-150-015854401500150 mL in 1 CONTAINER50 mlHistorical
58544-150-02585440150021 CONTAINER in 1 CARTON (58544-150-02) / 50 mL in 1 CONTAINER (58544-150-01) 1 container2026-03-01NoNoCurrent