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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4Y5P7MUD51	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
5A68WGF6WM	Internal UNII lookup
G63QQF2NOX	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
50cf1d88-3e7e-47b7-816a-3d579bde0a6a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8234c772-5c41-424c-a33e-e06e8c4de9c1	Product name	2	20250626
fbe2ea47-480e-f5f1-0d64-c87fd5ac923b	Product name	4	20250224
510b43a3-8143-a25f-19c6-476c90dbb618	Product name	9	20171115

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 240 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ISA KNOX ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	fmg Co.Ltd	d6dcdb08-3407-90e1-e053-2a95a90a83bf	2025-01-01	Warnings	Exact identifier application number: M020
ISA KNOX ANEW SOLAIRE ACTIVE FACE AND BODY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	fmg Co.Ltd	d6de8135-3c70-2036-e053-2995a90a040b	2025-01-01	Warnings	Exact identifier application number: M020
ISA KNOX LXNEW PLATINUM SCULPTING DAY BROAD SPECTRUM SPF 30 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	fmg Co.Ltd	d6deadbd-524f-7506-e053-2a95a90a0a1b	2025-01-01	Warnings	Exact identifier application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN	ZINC OXIDE	fmg Co.Ltd	02e61a43-3021-edc1-e063-6294a90ad4b6	2025-01-01	Warnings	Exact identifier application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	fmg Co.Ltd	02e64868-d545-4af7-e063-6394a90aa7c7	2025-01-01	Warnings	Exact identifier application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN	ZINC OXIDE	fmg Co.Ltd	f114e45c-6c31-2382-e053-2995a90ac754	2025-01-01	Warnings	Exact identifier application number: M020
OHUI Ultimate Cover CC Cushion Compact 01 Light Beige	TITANIUM DIOXIDE	fmg Co.Ltd	d3078dd2-ae9c-d81a-e053-2a95a90a47bf	2025-01-01	Warnings	Exact identifier application number: M020
OHUI Ultimate Cover CC Cushion Compact 02 Natural Beige	TITANIUM DIOXIDE	fmg Co.Ltd	d3078dd2-ae9e-d81a-e053-2a95a90a47bf	2025-01-01	Warnings	Exact identifier application number: M020
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREEN	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	fmg Co.Ltd	f8377d02-6c58-c240-e053-6294a90a44c0	2025-01-01	Warnings	Exact identifier application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	fmg Co.Ltd	d67faeb3-0b73-5b6e-e053-2a95a90aac2b	2025-01-01	Warnings	Exact identifier application number: M020
belif The true cream aqua bomb sunscreen Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	fmg Co.Ltd	02e63ed6-1f49-45c0-e063-6394a90a58bf	2025-01-01	Warnings	Exact identifier application number: M020
Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50	ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	fmg Co.Ltd	d2fadd51-6bd8-ae70-e053-2995a90a6213	2025-01-01	Warnings	Exact identifier application number: M020
Jergens Natural Glow Face Moisturizer Medium to Deep Skin Tones	AVOBENZONE,OCTISALATE, OCTOCRYLENE	Kao USA Inc.	ff601f5c-b8ed-ee21-e053-6294a90aadba	2025-01-01	Warnings	Exact identifier application number: M020
THEFACESHOP Cushion CC SPF 50 Apricot Beige Oil-Free	ENSULIZOLE, TITANIUM DIOXIDE	LG H&H Co., Ltd.	d309eebc-44f4-bce6-e053-2995a90a3bd2	2025-01-01	Warnings	Exact identifier application number: M020
THEFACESHOP Cushion CC SPF 50 Natural Beige Oil-Free	ENSULIZOLE, TITANIUM DIOXIDE	LG H&H Co., Ltd.	d30a3bcb-5113-0a85-e053-2995a90a3937	2025-01-01	Warnings	Exact identifier application number: M020
THEFACESHOP Natural Sun Oil-Free Sunscreen Broad Spectrum SPF 50	ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LG H&H Co., Ltd.	d30a9f96-f99b-4610-e053-2995a90a3f91	2025-01-01	Warnings	Exact identifier application number: M020
THEFACESHOP Cushion CC Total Cover SPF 50 Apricot Beige	ENSULIZOLE, TITANIUM DIOXIDE	LG H&H Co., Ltd.	d30a7ecc-ea54-d1b9-e053-2995a90a7017	2025-01-01	Warnings	Exact identifier application number: M020
THEFACESHOP Cushion CC Total Cover SPF 50 Natural Beige	ENSULIZOLE, TITANIUM DIOXIDE	LG H&H Co., Ltd.	d30a87b9-90f9-35b2-e053-2995a90aea2c	2025-01-01	Warnings	Exact identifier application number: M020
THEFACESHOP Natural Sun Long Lasting Sunscreen Broad Spectrum SPF 50	ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LG H&H Co., Ltd.	d30ab7a5-d38c-ba62-e053-2995a90a57fd	2025-01-01	Warnings	Exact identifier application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H Co., Ltd.	d6e82b4e-ce83-0ca2-e053-2a95a90a88de	2025-01-01	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
87482-001_PRVWORA Ultra Defense Sunscreen	Cellarkbio Inc. \| OTCM JANGHANG FACTORY	2026-04-04	HUMAN OTC DRUG LABEL	1