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 115 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral SunscreenZINC OXIDEISIS GONZALEZ3f68b2ea-be23-100d-e063-6294a90a8b372025-12-16WarningsExact identifier
application number: M020
Mineral SunscreenZINC OXIDEISIS GONZALEZ3f682b78-e1c9-e174-e063-6294a90a17ed2025-12-16WarningsExact identifier
application number: M020
Silk Screen TintedTITANIUM DIOXIDE, ZINC OXIDESkin Science Institute Inc36c3793a-ccb5-1e5f-e063-6294a90ad44f2025-12-16Exact identifier
application number: M020
Silk Screen TintedTITANIUM DIOXIDE, ZINC OXIDESkin Science Institute Inc36c3a721-6be1-3f7f-e063-6394a90a522f2025-12-16Exact identifier
application number: M020
True Tone TintedTITANIUM DIOXIDE, ZINC OXIDEThat Face PLLC36c2bb0e-479d-89cd-e063-6294a90aa3d42025-12-16Exact identifier
application number: M020
True Tone Non TintedZINC OXIDEThat Face PLLC36c2f263-67cf-e8cf-e063-6394a90ad81f2025-12-16Exact identifier
application number: M020
Tinted Daily Protection SunscreenZINC OXIDEKemmi Lee Skin Science37ef5a05-54d2-a8e4-e063-6394a90a8e482025-12-16Exact identifier
application number: M020
Aquaphor Lip Repair Stick and SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE,Beiersdorf Incd469bddf-90d4-7b1c-e053-2a95a90a1ed92025-12-16WarningsExact identifier
application number: M020
Eucerin Daily Protection FaceENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEBeiersdorf Inc76403f03-aee9-4c0b-b331-f79b6953118c2025-12-16WarningsExact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c0400b-8ad9-654b-e063-6294a90ad0402025-12-16Exact identifier
application number: M020
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c00301-ee41-333c-e063-6294a90a61d52025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c078fa-05f9-ad80-e063-6394a90af3bb2025-12-16Exact identifier
application number: M020
20Percent Zinc Oxide Non TintedZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c108f6-a928-0a54-e063-6394a90ae6862025-12-16Exact identifier
application number: M020
20Percent Zinc Oxide Non TintedZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c0ccca-c993-181e-e063-6294a90a7ae62025-12-16Exact identifier
application number: M020
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c0a55d-16d3-086a-e063-6394a90a30cf2025-12-16Exact identifier
application number: M020
Eucerin Radiant ToneAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBeiersdorf Inc2611e0cb-d56d-6ea1-e063-6294a90a745b2025-12-16WarningsExact identifier
application number: M020
Really Great Lip ShieldTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c1341d-fbf5-56a5-e063-6294a90aa0452025-12-16Exact identifier
application number: M020
Tinted Mineral SunscreenZINC OXIDEKLOE SALON LLC36c23c07-2011-3ddb-e063-6294a90a76e92025-12-16Exact identifier
application number: M020
Tinted Mineral Sun DefenseTITANIUM DIOXIDE, ZINC OXIDEHelen's Haven36c465ea-979b-9474-e063-6394a90ab3f82025-12-16Exact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHelen's Haven36c4a27b-96e9-4f30-e063-6294a90a56552025-12-16Exact 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