Ultra Violette Preen Screen Broad Spectrum SPF 50

Product NDC: 84803-101
11-digit product format: 848030101
Labeler code: 84803
Product ID: 84803-101_533cb134-43ee-e843-e063-6294a90a38a1
Type: HUMAN OTC DRUG
Nonproprietary name: AVONBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE
Dosage form: SPRAY
Route: TOPICAL
Labeler: Grace and Fire USA Inc.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-12-01
Substance: OCTISALATE; OCTOCRYLENE; HOMOSALATE; AVOBENZONE
Active strength: 50; 60; 100; 30 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: Ultra Violette Preen Screen Broad Spectrum SPF 50
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTISALATE	50 mg/mL
OCTOCRYLENE	60 mg/mL
HOMOSALATE	100 mg/mL
AVOBENZONE	30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4X49Y0596W	Internal UNII lookup
5A68WGF6WM	Internal UNII lookup
V06SV4M95S	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
26a0fc0d-a903-2ac1-e063-6394a90a13db	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84803-101-30	ULTRA VIOLETTE SPF ON THE GLOWDuo Pack Kit	30 mL in 1 BOTTLE, SPRAY	SPRAY	1 mL in 30	30 mg in 1mL	4
84803-101-30	Ultra Violette Preen Screen Broad Spectrum SPF 50	30 mL in 1 BOTTLE, SPRAY	SPRAY	30		2
84803-101-50	Ultra Violette Preen Screen Broad Spectrum SPF 50	50 mL in 1 BOTTLE, SPRAY	SPRAY	50		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84803-101	ULTRA VIOLETTE PREEN SCREEN BROAD SPECTRUM SPF 50 (AVONBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) SPRAY [GRACE AND FIRE USA INC.]	1	Current NDC, 2 package rows	20241202_26a0fc0d-a903-2ac1-e063-6394a90a13db.zip

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 250 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
3LAB WW DAY SPF40 BROAD SPECTRUM	HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE	3LAB, INC	2a2f5f9a-4e2f-4bbb-e063-6294a90ab99e	2024-12-26	Warnings	Exact identifier application number: M020
MILANI MAKE IT LAST SUNSCREEN SETTING SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Cosmax Usa, Corporation	30b224f0-43f1-4c79-839e-3a970e4be3a5	2024-12-26	Warnings	Exact identifier application number: M020
CLINIQUE TARGETED PROTECTION SPF 45 BROAD SPECTRUM SUNSCREEN	HOMOSALATE, OCTISALATE, AND AVOBENZONE	CLINIQUE LABORATORIES LLC	f4fe22b3-ccf2-4d67-8d20-5b5d3b69b444	2024-12-25	Warnings	Exact identifier application number: M020
CITY BLOCK SHEER Oil FREE DAILY FACE PROTECTOR BROAD SPECTRUM SPF 25	TITANIUM DIOXIDE AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	ee7e2ded-b850-4e15-96a6-556111e52187	2024-12-25	Warnings	Exact identifier application number: M020
CLINIQUE SUPER DEFENSE CITY BLOCK DAILY ENERGY PLUS FACE PROTECTOR BROAD SPECTRUM SPF 50	OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	d1a3d76f-16dd-4533-8144-9a3175f6e15f	2024-12-25	Warnings	Exact identifier application number: M020
DOUBLE WEAR MAXIMUM COVER CAMOUFLAGE MAKEUP FOR FACE AND BODY BROAD SPECTRUM SPF 15	TITANIUM DIOXIDE	ESTEE LAUDER INC	a04a9aaa-fa0f-4dde-a7a5-c4c561cc51b1	2024-12-25	Warnings	Exact identifier application number: M020
ESTEE LAUDER MULTI-DEFENSE AQUA UV gel BROAD SPECTRUM SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	ESTEE LAUDER INC	0770e251-95d0-43de-88f1-bc0a29811e4e	2024-12-25	Warnings	Exact identifier application number: M020
MAC PREP AND PRIME FACE PROTECT BROAD SPECTRUM SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	MAKEUP ART COSMETICS	c26ef380-1309-4a41-862f-eb319d38673d	2024-12-25	Warnings	Exact identifier application number: M020
STUDIO FIX FLUID SPF 15 BROAD SPECTRUM	OCTINOXATE AND TITANIUM DIOXIDE	MAKEUP ART COSMETICS	ff48435d-245a-4037-9afb-caee83c4c415	2024-12-25	Warnings	Exact identifier application number: M020
ORIGINS GINZING ENERGY-BOOSTING TINTED MOISTURIZER BROAD SPECTRUM SPF 40	OCTINOXATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDE	ORIGINS NATURAL RESOURCES INC.	0fe63edf-7a49-4b33-88f1-f480f889d194	2024-12-25	Warnings	Exact identifier application number: M020
DR. ANDREW WEIL FOR ORIGINS MEGA-BRIGHT SPF 30 SKIN TONE CORRECTING oil FREE MOISTURIZER BROAD SPECTRUM SPF 30	HOMOSALATE, OCTISALATE, AVOBENZONE, AND OCTOCRYLENE	ORIGINS NATURAL RESOURCES INC.	8e8c495e-d439-4735-a7cc-b44081b75b27	2024-12-25	Warnings	Exact identifier application number: M020
VITAZING SPF 15 ENERGY BOOSTING MOISTURIZER WITH MANGOSTEEN BROAD SPECTRUM SPF 15	AVOBENZONE, OCTISALATE, AND OCTOCRYLENE	ORIGINS NATURAL RESOURCES INC.	0fac5204-df18-4774-bb53-115513cb7ff0	2024-12-25	Warnings	Exact identifier application number: M020
LA MER THE LUMINOUS LIFTING CUSHION FOUNDATION BROAD SPECTRUM SPF 20	TITANIUM DIOXIDE	MAX HUBER RESEARCH LAB INC	66e48ce0-9a5b-4250-b07b-1622b3814c3e	2024-12-25	Warnings	Exact identifier application number: M020
ESTEE LAUDER DOUBLE WEAR SHEER LONG-WEAR MAKEUP BROAD SPECTRUM SPF 19	OCTINOXATE AND TITANIUM DIOXIDE	ESTEE LAUDER INC	2f93580c-c8e9-4822-91bf-a749cf4deb4e	2024-12-25	Warnings	Exact identifier application number: M020
Buildable Blur	HOMOSALATE, OCTISALATE, ZINC OXIDE	COSMAX USA, CORPORATION	06b14a17-cab9-1b3e-e063-6394a90afe5d	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	06ab109e-abcf-0861-e063-6394a90a9375	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0d3379ba-465d-a889-e063-6394a90aaf23	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0d339273-6d82-0979-e063-6394a90a3de7	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0cc97b34-e9e6-ef6a-e063-6394a90aee89	2024-12-25	Warnings	Exact identifier application number: M020
Leg Body Makeup	OCTISALATE, OCTOCRYLENE	COSMAX USA, CORPORATION	0cc9760b-b88b-f291-e063-6294a90a242f	2024-12-25	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
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
84803-101-30	84803010130	30 mL in 1 BOTTLE, SPRAY (84803-101-30)	30 ml	2024-12-01	No	No	Current
84803-101-50	84803010150	50 mL in 1 BOTTLE, SPRAY (84803-101-50)	50 ml	2024-12-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ultra Violette Preen Screen Broad Spectrum SPF 50 - Grace and Fire USA Inc.	Grace and Fire USA Inc.	2026-06-01	HUMAN OTC DRUG LABEL	3
ULTRA VIOLETTE SPF ON THE GLOW Duo Pack Kit	Grace And Fire USA Inc.	2026-01-06	HUMAN OTC DRUG LABEL	4
ULTRA VIOLETTE SPF ON THE GLOW - SPF 50 Duo Pack Kit	Thermo-Pak Company, Inc.	2025-11-03	HUMAN OTC DRUG LABEL	1