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 180 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Premium Moisturizing Sunscreen Broad Spectrum SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWasatch Product Development, LLCf4346f7a-3642-05d8-e053-2a95a90a013d2025-10-09WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWasatch Product Development, LLCf4206dad-6a17-2f56-e053-2a95a90a69dc2025-10-09WarningsExact identifier
application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWasatch Product Development, LLCf434089c-126f-441c-e053-2995a90ab0c72025-10-09WarningsExact identifier
application number: M020
BEAUTY SHIELD BROAD SPECTRUM SUNSCREEN (Napoleon Perdis)ZINC OXIDENapoleon PerdisCosmetic Pty Ltdbe64bb40-b1a9-2308-e053-2a95a90a69c82025-10-09WarningsExact identifier
application number: M020
Organys Open Formula SheerZINC OXIDEOrganys Beauty0b3ab551-cb66-cf86-e063-6394a90a7ab42025-10-09WarningsExact identifier
application number: M020
Dr Lift Mineral SPF 50TITANIUM DIOXIDE, ZINC OXIDESpa de Soleil40c03d65-8d09-371a-e063-6294a90a7ac62025-10-09WarningsExact identifier
application number: M020
Organys Derma Made SheerZINC OXIDEOrganys Beauty0b39f550-bd34-509d-e063-6294a90a51d02025-10-09WarningsExact identifier
application number: M020
Organys Derma MadeZINC OXIDEOrganys Beauty0b37a73b-73ca-501f-e063-6294a90a62912025-10-09WarningsExact identifier
application number: M020
Organys Derma MadeZINC OXIDEOrganys Beauty09b8b8c0-4066-9cbe-e063-6394a90aca242025-10-09WarningsExact identifier
application number: M020
Dr Lift Mineral SPF 30TITANIUM DIOXIDESpa de Soleil40c0e0d2-2c1d-e629-e063-6394a90a5aaf2025-10-09WarningsExact identifier
application number: M020
Daybird Tinted Skincare (SHADE 3)ZINC OXIDEResette, Incdc89ab76-da32-4f6f-e053-2995a90a8bcb2025-10-09WarningsExact identifier
application number: M020
Daybird Tinted Skincare (SHADE 4)ZINC OXIDEResette, Incdc89ab0b-d53e-983f-e053-2a95a90a127f2025-10-09WarningsExact identifier
application number: M020
Petroleum-Free Lip BalmOCTINOXATE AND OXYBENZONEMedline Industries, LP6125d98a-6fc7-4f50-924e-3b1f7ee951f42025-10-09WarningsExact identifier
application number: M020
Daybird Tinted Skincare (SHADE 1)ZINC OXIDEResette, Incdc89429a-022c-dd10-e053-2a95a90ac26a2025-10-09WarningsExact identifier
application number: M020
Daybird Tinted Skincare (SHADE 2)ZINC OXIDEResette, Incdc89ab76-da2f-4f6f-e053-2995a90a8bcb2025-10-09WarningsExact identifier
application number: M020
Dr Lift SPF 50 Clear StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESpa de Soleil40c11b19-fc91-2033-e063-6394a90a5a5f2025-10-09WarningsExact identifier
application number: M020
Black Girl Sunscreen Make It Mineral BabyZINC OXIDEBlack Girl Sunscreen302bccc6-7bf3-cc69-e063-6294a90a625c2025-10-09WarningsExact identifier
application number: M020
Babo Botanicals Sheer Zinc Mineral Sunscreen SPF30ZINC OXIDEBabo Botanicals, Inc.08f0436b-85b6-5099-e063-6294a90a4c2e2025-10-09WarningsExact identifier
application number: M020
CoreTex Professional Outdoor Skin Protection WalletCORETEX PROFESSIONAL OUTDOOR SKIN PROTECTION WALLETCoreTex Products Incf57bc089-405b-cdcd-e053-2995a90a9d122025-10-09WarningsExact identifier
application number: M020
Mist Me SPF-40ZINC OXIDECove Suncare LLCb7f09089-54a4-4f60-b632-e3f4321313ec2025-10-09WarningsExact 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