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 246 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ulta Beauty Tinted Moisturizer Cream Spf 24 MediumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporationfbc0ff10-fb2f-e637-e053-6294a90a0c292024-12-26WarningsExact identifier
application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 DeepAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporation2984c64f-eaac-ecb6-e063-6394a90aeb122024-12-26WarningsExact identifier
application number: M020
Ulta Beauty Tinted Moisturizer Cream Spf 24 TanAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporation2984a014-a56f-753b-e063-6294a90a13f52024-12-26WarningsExact identifier
application number: M020
Julep No Excuses Gel for Face SPF40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporation298404c4-d4be-7395-e063-6294a90a86bf2024-12-26WarningsExact identifier
application number: M020
Cover FX Invisible Primer SPF30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporation2983dd7c-7ca7-e952-e063-6394a90a30982024-12-26WarningsExact identifier
application number: M020
3LAB WW DAY SPF40 BROAD SPECTRUMHOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE3LAB, INC2a2f5f9a-4e2f-4bbb-e063-6294a90ab99e2024-12-26WarningsExact identifier
application number: M020
MILANI MAKE IT LAST SUNSCREEN SETTING SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECosmax Usa, Corporation30b224f0-43f1-4c79-839e-3a970e4be3a52024-12-26WarningsExact identifier
application number: M020
CLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREENHOMOSALATE, OCTISALATE, AND AVOBENZONECLINIQUE LABORATORIES LLCf4fe22b3-ccf2-4d67-8d20-5b5d3b69b4442024-12-25WarningsExact identifier
application number: M020
CITY BLOCK SHEER Oil FREE DAILY FACE PROTECTOR BROAD SPECTRUM SPF 25TITANIUM DIOXIDE AND ZINC OXIDECLINIQUE LABORATORIES LLCee7e2ded-b850-4e15-96a6-556111e521872024-12-25WarningsExact identifier
application number: M020
CLINIQUE SUPER DEFENSE CITY BLOCK DAILY ENERGY PLUS FACE PROTECTOR BROAD SPECTRUM SPF 50OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLCd1a3d76f-16dd-4533-8144-9a3175f6e15f2024-12-25WarningsExact identifier
application number: M020
DOUBLE WEAR MAXIMUM COVER CAMOUFLAGE MAKEUP FOR FACE AND BODY BROAD SPECTRUM SPF 15TITANIUM DIOXIDEESTEE LAUDER INCa04a9aaa-fa0f-4dde-a7a5-c4c561cc51b12024-12-25WarningsExact identifier
application number: M020
ESTEE LAUDER MULTI-DEFENSE AQUA UV gel BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEESTEE LAUDER INC0770e251-95d0-43de-88f1-bc0a29811e4e2024-12-25WarningsExact identifier
application number: M020
MAC PREP AND PRIME FACE PROTECT BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEMAKEUP ART COSMETICSc26ef380-1309-4a41-862f-eb319d38673d2024-12-25WarningsExact identifier
application number: M020
STUDIO FIX FLUID SPF 15 BROAD SPECTRUMOCTINOXATE AND TITANIUM DIOXIDEMAKEUP ART COSMETICSff48435d-245a-4037-9afb-caee83c4c4152024-12-25WarningsExact identifier
application number: M020
ORIGINS GINZING ENERGY-BOOSTING TINTED MOISTURIZER BROAD SPECTRUM SPF 40OCTINOXATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDEORIGINS NATURAL RESOURCES INC.0fe63edf-7a49-4b33-88f1-f480f889d1942024-12-25WarningsExact identifier
application number: M020
DR. ANDREW WEIL FOR ORIGINS MEGA-BRIGHT SPF 30 SKIN TONE CORRECTING oil FREE MOISTURIZER BROAD SPECTRUM SPF 30HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENEORIGINS NATURAL RESOURCES INC.8e8c495e-d439-4735-a7cc-b44081b75b272024-12-25WarningsExact identifier
application number: M020
VITAZING SPF 15 ENERGY BOOSTING MOISTURIZER WITH MANGOSTEEN BROAD SPECTRUM SPF 15AVOBENZONE, OCTISALATE, AND OCTOCRYLENEORIGINS NATURAL RESOURCES INC.0fac5204-df18-4774-bb53-115513cb7ff02024-12-25WarningsExact identifier
application number: M020
LA MER THE LUMINOUS LIFTING CUSHION FOUNDATION BROAD SPECTRUM SPF 20TITANIUM DIOXIDEMAX HUBER RESEARCH LAB INC66e48ce0-9a5b-4250-b07b-1622b3814c3e2024-12-25WarningsExact identifier
application number: M020
ESTEE LAUDER DOUBLE WEAR SHEER LONG-WEAR MAKEUP BROAD SPECTRUM SPF 19OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC2f93580c-c8e9-4822-91bf-a749cf4deb4e2024-12-25WarningsExact identifier
application number: M020
Buildable BlurHOMOSALATE, OCTISALATE, ZINC OXIDECOSMAX USA, CORPORATION06b14a17-cab9-1b3e-e063-6394a90afe5d2024-12-25WarningsExact 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