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 159 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Invisible Sunscreen SPF 40HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENEPARTICLE AESTHETIC SCIENCE LTD1b33b4fb-1deb-69f7-e063-6294a90a9cc02025-11-19WarningsExact identifier
application number: M020
Softlips VanillaDIMETHICONE, OCTINOXATE, OCTISALATE, OXYBENZONEThe Mentholatum Company8dff782f-7201-4ad9-94d2-672058f817b82025-11-19WarningsExact identifier
application number: M020
Illuminizing Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC43e36351-4caf-3393-e063-6394a90a00b12025-11-18WarningsExact identifier
application number: M020
Perfecting Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC43e454cf-dac8-4c2f-e063-6394a90a70972025-11-18WarningsExact identifier
application number: M020
Hill Country Fare Morning Facial Moisturizing with Broad Spectrum SPF 30 SunscreenHOMOSALATE, OCTOCRYLENE, ZINC OXIDEH.E.B.43e55eb7-6572-bd88-e063-6294a90aa7ee2025-11-18WarningsExact identifier
application number: M020
ANTI-AGING COMPLEX BROAD SPECTRUM SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONEMerle Norman Cosmetics, Inc.d10272ea-aedd-5759-e053-2a95a90a3ab32025-11-18WarningsExact identifier
application number: M020
DAYDREAM Broad Spectrum Sunscreen SPF 40ZINC OXIDEDrmtlgy, LLCbd0981cb-49ce-4eaf-bd9e-db48f56b73142025-11-18WarningsExact identifier
application number: M020
SPF 25 LIP BALMAVOBENZONE, OCTISALATE, HOMOSALATEDrmtlgy, LLC8aed2fb0-f7b8-4ff0-b597-144c0557789e2025-11-18WarningsExact identifier
application number: M020
Sunny Defense Sunscreen StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERBGROUP Co., Ltd262450f0-c4a1-dcca-e063-6394a90ae3cd2025-11-17WarningsExact identifier
application number: M020
Tone Blur Essence SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERBGROUP Co., Ltd1814b5e7-5bbf-df16-e063-6294a90a96c42025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 17NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c48c66-bd5b-0024-e063-6394a90a6c7b2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 19COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c512da-e4b6-dd9c-e063-6294a90a17302025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 21NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c52258-2549-c42b-e063-6394a90a15262025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 21WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c59de6-8eb2-d00a-e063-6294a90a0b042025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 24WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c5bd02-62e0-019a-e063-6294a90adcf32025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 23WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c5d54e-119c-0c6d-e063-6394a90aba4c2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 25NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c5eb1c-b268-acfb-e063-6394a90ad4cc2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 27COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c6157a-4b62-8279-e063-6294a90abe052025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 27WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c6252f-56b8-9e3c-e063-6294a90aa12c2025-11-17WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER MINI 28NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.43c62e80-9ace-c1f2-e063-6294a90a5bfa2025-11-17WarningsExact 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