FDA.reportPublic FDA data

PRVWORA Ultra Defense Sunscreen

Product NDC
87482-001
11-digit product format
874820001
Labeler code
87482
Product ID
87482-001_4e9f781d-6b07-b69a-e063-6394a90a36c8
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octinoxate, Octisalate, Octocrylene
Dosage form
CREAM
Route
TOPICAL
Labeler
Cellarkbio Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-04
Substance
OCTINOXATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE
Active strength
72.5; 45; 95; 28.5 mg/mL; mg/mL; mg/mL; mg/mL
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
PRVWORA Ultra Defense Sunscreen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE72.5 mg/mL
OCTISALATE45 mg/mL
OCTOCRYLENE95 mg/mL
AVOBENZONE28.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
50cf1d88-3e7e-47b7-816a-3d579bde0a6aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8234c772-5c41-424c-a33e-e06e8c4de9c1Product name220250626
fbe2ea47-480e-f5f1-0d64-c87fd5ac923bProduct name420250224
510b43a3-8143-a25f-19c6-476c90dbb618Product name920171115

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87482-001-01PRVWORA Ultra Defense Sunscreen50 mL in 1 TUBECREAM501
87482-001-02PRVWORA Ultra Defense 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 64 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC232ab407-1903-45d8-a2b2-6992ffd30d002026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC0ccef180-0eb1-cf2b-e063-6394a90adf0c2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen for Kids SPF 50AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC6a455f1a-4285-44c3-820a-85a50d1bbc5b2026-02-06WarningsExact identifier
application number: M020
Sport Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC15bf22f5-a8f5-44bb-b787-2b762b330d612026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Sport Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC6d1ad14e-afc6-4676-87d7-3e50e3a02fe92026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen for Babies SPF 50AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC64766ed9-bd47-498d-bf59-fb30a7bf7e892026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Broad Spectrum Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLCccb651f6-e567-4c5f-9109-8767270cc4be2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC80dcd255-3a6c-4b79-b081-519c9dac990a2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Moisturizing Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Service, LLC9de8b6b1-024b-4b71-96e6-fea68088d3ab2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
SunscreenSUNSCREENRetail Business Services, LLC96221c10-ebfe-4385-b6b5-d504258df36c2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Moisturizing Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLCe2adbde9-3c8b-45f3-b4ef-4936b88d812d2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
NUDESCREEN DEWY ILLUMINATING GLOW SPF 30 - Sunkissed GlowZINC OXIDE SUNSCREENBentley Laboratories, LLCbf1a237b-b27e-4c55-8ded-e348240a5b9a2026-02-06WarningsExact identifier
application number: M020
SEYTU Body SunscreenTITANIUM DIOXIDE AND ZINC OXIDEOmnilife USA, Inc.c411e9a6-b2ea-446b-a886-b92c61736e6c2026-02-05WarningsExact identifier
application number: M020
SEYTU Facial SunscreenTITANIUM DIOXIDE AND ZINC OXIDEOmnilife USA, Inc.96fd37fb-c3ff-413f-b2c8-50754f320ecc2026-02-05WarningsExact identifier
application number: M020
Sun Veil IlluminatingElixir Face Sunscreen SPF 38OCTISALATE, OCTOCRYLENE, ZINC OXIDEKoco Life LLC4a15c479-d676-9e52-e063-6394a90a4eb42026-02-05WarningsExact identifier
application number: M020
Golden Sunglaze Sheer Body Mist Sunscreen SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKoco Life LLC22d0a5db-6af1-a3ca-e063-6394a90a68ef2026-02-05WarningsExact identifier
application number: M020
Sunglaze Sheer Setting Mist Sunscreen SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTYOCRYLENEKoco Life LLC22ce9b26-2bf8-c1ea-e063-6394a90a8ec22026-02-05WarningsExact identifier
application number: M020
Peppermint SPF 15 Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENENaples Soap Company, Inc.24adffd4-5177-f5d5-e063-6294a90a78502026-02-05WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 BambooOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASebfe03e7-614f-44b1-b1f1-78edc7e274cc2026-02-05WarningsExact identifier
application number: M020
Serious Skincare Serious-C3 Plasma Bio Technology C Cream SPF 30AVOBENZONE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONEFlageoli Limited66f29201-6cbe-46d0-b54c-005a1ecefac42026-02-04WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87482-001-018748200010150 mL in 1 TUBE50 mlHistorical
87482-001-02874820001021 TUBE in 1 CARTON (87482-001-02) / 50 mL in 1 TUBE (87482-001-01) 1 tube2026-04-04NoNoCurrent