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 238 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ECLIPSE SPF 50 ALL SHADESTITANIUM DIOXIDE, ZINC OXIDESCIENCE OF SKINCARE LLC49df51e6-be9a-41be-b3e1-bfc062aaceaa2025-01-09WarningsExact identifier
application number: M020
CoTZ Mineral Suns Stick - Tinted SPF 45TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD44a6ff9b-8067-4f32-acb2-4ede54c79e6e2025-01-09WarningsExact identifier
application number: M020
NUDESCREEN BLUSH TINT SPF 30 - SUNKISSEDZINC OXIDE SUNSCREENBentley Laboratories, LLCc45b59d8-0196-4dce-bfaa-57c47f655fe82025-01-09WarningsExact identifier
application number: M020
TiZO Tinted Lip Protection SPF 45TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD81ee1b28-c7d7-4b34-b0f0-5a3cc7a139a22025-01-09WarningsExact identifier
application number: M020
CoTZ Face Prime and Protect SPF 40 (Tinted)TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD1088fbf6-5790-490d-b272-ec281b4b76fa2025-01-09WarningsExact identifier
application number: M020
CoTZ Face Prime and Protect SPF 40 (Non-Tinted)TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDf106f52b-2157-46c7-9f7c-50f43a6490502025-01-09WarningsExact identifier
application number: M020
NUDESCREEN BLUSH TINT SPF 30 - SUNNY SWEET CHEEKSZINC OXIDE SUNSCREENBentley Laboratories, LLC5c98bacb-8bbd-47b8-8987-50be1ed34fc02025-01-09WarningsExact identifier
application number: M020
CoTZ Face MoistureZINC OXIDEFallien Cosmeceuticals, LTDdb682516-6c8f-4009-a9ec-e21dfc64ce152025-01-09WarningsExact identifier
application number: M020
L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 Light MediumOCTOCRYLENE, ZINC OXIDEL'BRI Health & Beautybcd22c9a-2db6-4653-9ab5-825f3f5cc4202025-01-08WarningsExact identifier
application number: M020
L Bri CC DD Color Correcting Daily Defense Sunscreen SPF 30 LightOCTOCRYLENE, ZINC OXIDEL'BRI Health & Beautyc66c2a54-97c8-4904-a44a-b3cf790837f52025-01-08WarningsExact identifier
application number: M020
Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATETempo Industries, Inc.af9aa56d-2f8a-55b9-e053-2a95a90a32582025-01-08WarningsExact identifier
application number: M020
Baby Mineral Sunscreen Probiotics SPF55ZINC OXIDEHello Bello0191b2e4-bcc5-541a-e063-6294a90a0e782025-01-08WarningsExact identifier
application number: M020
Kids Face and Body Sunscreen SPF 50ZINC OXIDEHello Bello01cc4ea0-e3de-32f1-e063-6394a90a13752025-01-08WarningsExact identifier
application number: M020
Baby Mineral Sunscreen SPF55ZINC OXIDEHello Bello0190eeaf-c5a0-3253-e063-6294a90a43c42025-01-08WarningsExact identifier
application number: M020
Mineral Sunscreen SPF 50ZINC OXIDEHello Bello01cc205b-a345-262a-e063-6394a90a955c2025-01-08WarningsExact identifier
application number: M020
Eco Lips Zinc SPF 30 Broad Spectrum Sunscreen UnscentedZINC OXIDEEco Lips, Inc.febabad6-0bf2-a3f8-e053-6294a90a3aeb2025-01-08WarningsExact identifier
application number: M020
LESS EVERY TONE SPF 30ZINC OXIDEHappy Farm Botanicals, Inc.e91ded4b-987d-17a8-e053-2995a90adc2e2025-01-08WarningsExact identifier
application number: M020
Stay AgelessTinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEETHEREAL AESTHETICS LLC065d17cf-bea5-137f-e063-6394a90aeeb32025-01-08WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDESERRAO, E JOHN MD FACOGfea61544-6684-ad34-e053-6294a90a48f32025-01-08WarningsExact identifier
application number: M020
Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDENew Beginnings Tattoo Removalfea87de3-116f-4774-e053-6394a90a0aad2025-01-08WarningsExact 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