FDA.reportPublic FDA data

Pro-Sil SPF

Product NDC
84440-608
11-digit product format
844400608
Labeler code
84440
Product ID
84440-608_3c19544e-15e2-2a0f-e063-6394a90aee34
Type
HUMAN OTC DRUG
Nonproprietary name
Silicone stick with SPF
Dosage form
STICK
Route
TOPICAL
Labeler
Biodermis, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-08
Substance
OCTINOXATE; AVOBENZONE; OCTOCRYLENE
Active strength
40; 30; 50 mg/g; mg/g; mg/g
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
Pro-Sil SPF
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE40 mg/g
AVOBENZONE30 mg/g
OCTOCRYLENE50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
G63QQF2NOXInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3be06f82-935d-b1c2-e063-6294a90a953cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84440-608-01Pro-Sil SPF1 g in 1 TUBESTICK12
84440-608-17Pro-Sil SPF17 g in 1 TUBESTICK172
84440-608-42Pro-Sil SPF4.25 g in 1 TUBESTICK4.252

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 127 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Sunscreen Stick SPF 50 Fragrance-FreeZINC OXIDECOOLA LLCee8706b0-ad42-403a-be7c-b660f040a2442025-12-14WarningsExact identifier
application number: M020
COOLA CLASSIC SUNSCREEN FRAGRANCE FREEAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA, LLCcfc21b1a-4a26-1573-e053-2995a90a2d502025-12-14WarningsExact identifier
application number: M020
Kopari Sunglaze Sheer Body Mist Sunscreen SPF42AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKopari Beauty7c96b799-e24d-473f-8f0a-3fad83d5ed482025-12-14WarningsExact identifier
application number: M020
WOODSLEEP Sunscreen BalmTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.45cfc7ed-34a6-1f45-e063-6394a90a902b2025-12-13WarningsExact identifier
application number: M020
Universkin by Alma Daily Mineral Serum Broad Spectrum SPF50ZINC OXIDE 24%UNIVERSKIN45d242de-cbd8-e7ea-e063-6394a90aaebf2025-12-13WarningsExact identifier
application number: M020
Mineral SunscreenZINC OXIDE SPF 50ALAINA HEALTHCARE PRIVATE LIMITEDb7847d4f-2517-4b58-8e31-676c9d6e484d2025-12-12WarningsExact identifier
application number: M020
Lip ProtectingTITANIUM DIOXIDE, ZINC OXIDEJOHANNA'S SKIN CARE3544b8f2-2651-4c01-e063-6394a90ae53d2025-12-12Exact identifier
application number: M020
Tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEJOHANNA'S SKIN CARE3544faa1-ebdf-5dbd-e063-6394a90a76312025-12-12Exact identifier
application number: M020
Replenishing Daily Protection TintedZINC OXIDESOLUTIONS SKIN CARE LLC40323dfa-29e4-1464-e063-6294a90aa65c2025-12-12WarningsExact identifier
application number: M020
Zinc 20Percent SPF 40ZINC OXIDEJOHANNA'S SKIN CARE3545ed3e-b42f-d29d-e063-6394a90a8efe2025-12-12Exact identifier
application number: M020
Replenishing Daily Protection Non-TintedZINC OXIDESOLUTIONS SKIN CARE LLC40332cf3-e4e5-0c00-e063-6394a90a683d2025-12-12WarningsExact identifier
application number: M020
Replenishing Daily Protection Non-TintedZINC OXIDESOLUTIONS SKIN CARE LLC4032913b-4bc3-6920-e063-6294a90a6e2d2025-12-12WarningsExact identifier
application number: M020
Replenishing Daily Protection TintedZINC OXIDESOLUTIONS SKIN CARE LLC4032f0b0-c083-d227-e063-6394a90a30682025-12-12WarningsExact identifier
application number: M020
Everyday Mineral SunscreenZINC OXIDEMYRENE DULAY-MARTINEZ396d952b-22ff-567f-e063-6394a90a8c682025-12-12Exact identifier
application number: M020
Everyday Mineral SunscreenZINC OXIDEMYRENE DULAY-MARTINEZ396dfc9c-b6c0-5892-e063-6394a90a110c2025-12-12Exact identifier
application number: M020
KawaKids KawaSun - Premium Mineral Sunscreen SPF 50ZINC OXIDELCA COSMETICS LLC1f41f64b-d707-08e2-e063-6294a90aa9242025-12-12WarningsExact identifier
application number: M020
KawaKids KawaSun - Premium On-The-Go Mineral Sunscreen SPF 50ZINC OXIDELCA COSMETICS LLC1f4341f7-b499-3b73-e063-6394a90a75b82025-12-12WarningsExact identifier
application number: M020
Advanced Mineral SunscreenZINC OXIDECharisma Skin351f7f72-c426-e42f-e063-6294a90a4b3a2025-12-12Exact identifier
application number: M020
Advanced Mineral SunscreenZINC OXIDECharisma Skin351f06f3-9deb-4c1a-e063-6394a90ad7662025-12-12Exact identifier
application number: M020
Daily Mineral ProtectionZINC OXIDECharisma Skin352d72f6-06b9-6fdc-e063-6294a90ab4482025-12-12Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84440-608-01844400608011 g in 1 TUBE (84440-608-01) 1 g2025-08-08YesNoCurrent
84440-608-178444006081717 g in 1 TUBE (84440-608-17) 17 g2025-08-08NoNoCurrent
84440-608-42844400608424.25 g in 1 TUBE (84440-608-42) 4.25 g2025-08-08NoNoCurrent