FDA.reportPublic FDA data

SOLAR MILK SPF50

Product NDC
68577-197
11-digit product format
685770197
Labeler code
68577
Product ID
68577-197_29fe4dad-d1fc-e750-e063-6294a90ab307
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Dosage form
GEL
Route
TOPICAL
Labeler
COSMAX USA, CORPORATION
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-01
Substance
AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE
Active strength
3; 15; 10; 5 mg/mL; mg/mL; mg/mL; 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
SOLAR MILK SPF50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 mg/mL
HOMOSALATE15 mg/mL
OCTOCRYLENE10 mg/mL
OCTISALATE5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal 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
29fe4dad-d1fb-e750-e063-6294a90ab307Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-197-00SOLAR MILK SPF501 in 1 CARTONGEL11
68577-197-00SOLAR MILK SPF5050 mL in 1 BOTTLEGEL501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68577-197SOLAR MILK SPF50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) GEL [COSMAX USA, CORPORATION]1Current NDC, 2 package rows20241227_29fe4dad-d1fb-e750-e063-6294a90ab307.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 119 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Complexion Correction Primer Sunscreen clearTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357eee3c-1c21-5efb-e063-6294a90a4bb72025-12-15Exact identifier
application number: M020
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357e75ec-473e-df76-e063-6294a90a70c72025-12-15Exact identifier
application number: M020
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357f2f62-904a-2234-e063-6394a90aee722025-12-15Exact identifier
application number: M020
Superscreen Daytime Mineral SunscreenZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357f915a-bd77-350b-e063-6294a90ad27f2025-12-15Exact identifier
application number: M020
Complexion Correction Primer Sunscreen clearTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357ff025-84ad-6d77-e063-6394a90aad952025-12-15Exact identifier
application number: M020
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY358021a2-235b-825b-e063-6394a90a76f52025-12-15Exact identifier
application number: M020
Superscreen Daytime Mineral SunscreenZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY35805e66-18e6-0e45-e063-6294a90afe582025-12-15Exact identifier
application number: M020
Ultra Zinc Physical DefenseZINC OXIDEATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER35474ac4-8a9d-6a84-e063-6394a90a9bad2025-12-15Exact identifier
application number: M020
Ultra Zinc Physical DefenseZINC OXIDEATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER357e315e-8802-ad73-e063-6394a90a24952025-12-15Exact identifier
application number: M020
Tinted Physical DefenseTITANIUM DIOXIDE, ZINC OXIDEATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER35477ed2-0875-58d5-e063-6294a90a3d5d2025-12-15Exact identifier
application number: M020
Anti Aging Daily ProtectionZINC OXIDELEVERRIER, KAMILA35465f21-8bcd-6e44-e063-6294a90a8e5f2025-12-15Exact identifier
application number: M020
Anti Aging Daily ProtectionZINC OXIDELEVERRIER, KAMILA3546d369-3435-b56a-e063-6294a90a08432025-12-15Exact identifier
application number: M020
Tinted Facial SunscreenTITANIUM DIOXIDE, ZINC OXIDEHELTON SKIN & LASER INSTITUTE35a97770-2db9-99aa-e063-6294a90a459a2025-12-15Exact identifier
application number: M020
Tinted Replenishing Daily ProtectionZINC OXIDEHELTON SKIN & LASER INSTITUTE35a9d07d-70e5-5eed-e063-6394a90aebaf2025-12-15Exact identifier
application number: M020
Non-Tinted Sports StickTITANIUM DIOXIDE, ZINC OXIDEHELTON SKIN & LASER INSTITUTE35aa833a-19a1-99e9-e063-6394a90a840f2025-12-15Exact identifier
application number: M020
Tinted Facial PrimerTITANIUM DIOXIDE, ZINC OXIDEBEE NATURALS36c3352e-fa51-19ad-e063-6394a90a591b2025-12-15Exact identifier
application number: M020
Luminous Tinted MoisturizingZINC OXIDESKIN BOSS L.L.C.35a8ae26-82eb-e4ca-e063-6394a90a00222025-12-15Exact identifier
application number: M020
Restore Tinted MoisturizingZINC OXIDESKIN BOSS L.L.C.35a8e92e-ced2-fdcd-e063-6294a90acedc2025-12-15Exact identifier
application number: M020
Velvet Tinted Moisturizing Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN BOSS L.L.C.35a871dc-a707-9963-e063-6294a90a43962025-12-15Exact identifier
application number: M020
Velvet NT Moisturizing Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN BOSS L.L.C.35a8508d-7069-c2d6-e063-6394a90a62192025-12-15Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68577-197-00685770197001 BOTTLE in 1 CARTON (68577-197-00) / 50 mL in 1 BOTTLE1 bottle2024-09-01NoNoCurrent