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 207 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens SPF 50 Premium Moisturizing Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY0b2b1ed5-8e53-00f3-e063-6394a90a14f82025-06-24WarningsExact identifier
application number: M020
Walgreens Double Restorative Moisturizer Broad Spectrum SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY38569431-56b6-5f56-e063-6394a90ad24f2025-06-24WarningsExact identifier
application number: M020
Shade SPF30 Climate ControlOCTISALATE, OCTOCRYLENE, ZINC OXIDEMicro Current Technology, Inc.34080e9c-1637-cf25-e063-6394a90ace762025-06-24WarningsExact identifier
application number: M020
Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEAruba Aloe Balm NVcca65f6a-935f-48d4-a07d-831ab6027db02025-06-24WarningsExact identifier
application number: M020
Reef safe - Hydrating sunscreen SPF50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED385e8966-963d-0814-e063-6394a90a06e32025-06-24WarningsExact identifier
application number: M020
COLLAGEN GLOW MINERAL SUNSCREEN SPF 50ZINC OXIDENAKED SUNDAYS PTY LTDf76a4f0d-e3a6-4bd4-b1ab-09d690976d962025-06-23WarningsExact identifier
application number: M020
LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON ACIDO HIALURONICO FPS 20 SERUM FOUNDATION WITH HYALURONIC ACID SPF 20 CHAMPAGNE 170-NOCTINOXATE, ZINC OXIDEBEL STAR SAf459c27e-e607-47ba-e053-2a95a90a901f2025-06-22WarningsExact identifier
application number: M020
BISUTANG SunscreenBISUTANG SUNSCREENGuangdong Bisutang Biotechnology Co Ltd37fdb01b-929e-6a60-e063-6394a90a94e02025-06-20Exact identifier
application number: M020
AVON BEYOND GLOW SUN MILKAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENELG HOUSEHOLD & HEALTH CARE LTD.38045f75-42c0-7abb-e063-6294a90a8db62025-06-20WarningsExact identifier
application number: M020
Double Use Compact SPF 15 gold deluxe edition Claire 1-2-3OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBel Star S.A. (Colombia)b3747373-ef67-89ff-e053-2995a90afcde2025-06-20WarningsExact identifier
application number: M020
LBEL DIVINE Double Use compact SPF 15 gold deluxe edition Obscure 8-9ZINC OXIDE, TITANTIUM DIOXIDE, OCTINOXATEBel Star S.A. (Colombia)b5e47c63-7e82-34fc-e053-2a95a90a767c2025-06-20WarningsExact identifier
application number: M020
Proven Personalized Day Moisturizer Sunscreen SPF 30ZINC OXIDEProven Skincare5275d2c5-96e8-424d-a3c8-feea778191e42025-06-20WarningsExact identifier
application number: M020
LBEL CONCENTRE BASE SERUM ANTIEDAD EFECTO LIFTING FPS 15 ANTI AGING LIFTING SERUM FOUNDATION SPF 15 CHAMPAGNE 170-NOCTINOXATE, ZINC OXIDEBEL STAR SAf9266687-73d2-dac9-e053-6394a90ac2a12025-06-20WarningsExact identifier
application number: M020
LBEL DEFENSE TOTAL SUNSCREEN FOR FACE AND BODY SPF 50AVOBENZONE, HOMOSALATE, OCTOCRYLENEBEL STAR SAfd0465aa-df1e-ce1c-e053-6294a90a23022025-06-20WarningsExact identifier
application number: M020
FEIBTH TALLOW SUNSCREENTALLOW SUNSCREENGuangzhou Qiexiran Cosmetics Co., Ltd.37ead2b1-12d4-af92-e063-6394a90af0d62025-06-19WarningsExact identifier
application number: M020
LipBOMBTITANIUM DIOXIDE, ZINC OXIDEFLEUR DE VIE LLC37ef4c1e-2183-a277-e063-6394a90ae2df2025-06-19Exact identifier
application number: M020
Bioresist reinforcing effect face moisturizer SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBEL STAR S A99d7525d-b636-7f8e-e053-2a95a90a20802025-06-19WarningsExact identifier
application number: M020
Ultra Balm Moisturizing Protective Balm for lips SPF 20 Nude TranslucideOCTINOXATE, ZINC OXIDEBEL STAR S Ac4d56723-3953-fb8e-e053-2a95a90a69d32025-06-19WarningsExact identifier
application number: M020
SPF 50 Daily UV Defense Broad Spectrum SunscreenOCTINOXATE, ZINC OXIDEVi Medical Products, INC2d814f8a-23b5-209f-e063-6394a90a50912025-06-19WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY RIKI LLC37f2c5ed-c2f5-e569-e063-6294a90a15b12025-06-19Exact 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