Home NDC 87482-001 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 Ingredient Strength OCTINOXATE 72.5 mg/mL OCTISALATE 45 mg/mL OCTOCRYLENE 95 mg/mL AVOBENZONE 28.5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 87482-001-01 PRVWORA Ultra Defense Sunscreen 50 mL in 1 TUBE CREAM 50 1 87482-001-02 PRVWORA Ultra Defense Sunscreen 1 in 1 CARTON CREAM 1 1
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 12 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sun Juice Body Mist Sunscreen SPF30 - Cotton Candy Skies PARADISO AVOBENZONE, HOMOSALATE, OCTISALATE Koco Life LLC 568083ff-0da9-7f14-e063-6394a90a4301 2026-07-13 Warnings Exact identifier application number: M020 Sun Juice Body Mist Sunscreen SPF30 - Vanilla Breeze PARADISO AVOBENZONE, HOMOSALATE, OCTISALATE Koco Life LLC 3cc62c97-70c5-17f7-e063-6394a90abe25 2026-07-13 Warnings Exact identifier application number: M020 Norwex Lip Glaze Broad Spectrum SPF 30 Rose ZINC OXIDE Norwex Usa, Inc. 565feded-8e25-e628-e063-6294a90aee48 2026-07-11 Warnings Exact identifier application number: M020 PoutScreen Lip Treatment Lemon Meringue AVOBENZONE, OCTINOXATE, OCTOCRYLENE NAKED SUNDAYS PTY LTD 563e3ab9-4ee2-279c-e063-6294a90a7cf1 2026-07-10 Warnings Exact identifier application number: M020 INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - ROSY BROWN ZINC OXIDE COSMAX USA, CORPORATION 5643a73d-757c-702d-e063-6294a90a2c12 2026-07-10 Warnings Exact identifier application number: M020 INN BEAUTY SUN BALM SPF30 BROAD SPECTRUM LIP BALM - LATTE ZINC OXIDE COSMAX USA, CORPORATION 5643d655-e335-5643-e063-6394a90a483a 2026-07-10 Warnings Exact identifier application number: M020 MUSELY DAYCREAM SPF40 ZINC OXIDE COSMAX USA, CORPORATION 56443156-3edb-a643-e063-6394a90adf9f 2026-07-10 Warnings Exact identifier application number: M020 Hello Sun Silky Glow Broad Spectrum SPF40 ZINC OXIDE Cosmax USA, Corporation 56445f2d-8e5a-34eb-e063-6294a90ae26e 2026-07-10 Warnings Exact identifier application number: M020 Hello Kitty Fun Broad Spectrum SPF 40 ZINC OXIDE Cosmax USA Corporation 5644854e-18d6-617d-e063-6294a90ab3e7 2026-07-10 Warnings Exact identifier application number: M020 VERSED DAILY SUNSCREEN SPF 50 HOMOSALATE, OCTISALATE, AVOBENZONE COSMAX USA, CORP 5644ca1e-9032-d3fb-e063-6394a90a961e 2026-07-10 Warnings Exact identifier application number: M020 Hello Kitty Sunny Days Broad Spectrum SPF 40 ZINC OXIDE Cosmax USA Corporation 5644855d-f864-e07b-e063-6394a90a5148 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 ZINC OXIDE COSMAX USA, CORP 5644d49f-08b9-e806-e063-6294a90a80f9 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT NEUTRAL ZINC OXIDE COSMAX USA, CORP 564682e5-1051-9936-e063-6394a90abe1d 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT WRM ZINC OXIDE COSMAX USA, CORP 5646e069-5461-12c5-e063-6294a90abacb 2026-07-10 Warnings Exact identifier application number: M020 Protect Sport Sunscreen BROAD SPECTRUM SPF 30 Opal Day Spa 564704f2-b26a-d737-e063-6294a90aa6ff 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT MEDIUM NEUTRAL ZINC OXIDE COSMAX USA, CORP 5647162a-610e-2789-e063-6294a90a7549 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 LIGHT MEDIUM OLIVE ZINC OXIDE COSMAX USA, CORP 56472adb-572d-5a52-e063-6294a90a3cc3 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 MEDIUM COOL ZINC OXIDE COSMAX USA, CORP 56474782-beff-8437-e063-6294a90a8322 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 MEDIUM PEACH ZINC OXIDE COSMAX USA, CORP 564749f3-e820-9003-e063-6294a90a0265 2026-07-10 Warnings Exact identifier application number: M020 VERSED MULTI SERUM SKIN TINT SPF 40 TAN NEUTRAL ZINC OXIDE COSMAX USA, CORP 56477f58-3878-81fa-e063-6294a90a87b7 2026-07-10 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 87482-001-01 87482000101 50 mL in 1 TUBE 50 ml Historical 87482-001-02 87482000102 1 TUBE in 1 CARTON (87482-001-02) / 50 mL in 1 TUBE (87482-001-01) 1 tube 2026-04-04 No No Current