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 17 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ivory Perfecting Makeup Broad Spectrum SPF 25	OCTINOXATE, TITANIUM DIOXIDE	Merle Norman Cosmetics, Inc	552f25ba-61d5-6a94-e063-6394a90a46e9	2026-06-26	Warnings	Exact identifier application number: M020
Simply Beige Perfecting Makeup Broad Spectrum SPF 25	OCTINOXATE, TITANIUM DIOXIDE	Merle Norman Cosmetics, Inc	552f4799-9122-8db5-e063-6394a90a5132	2026-06-26	Warnings	Exact identifier application number: M020
Vanilla Perfecting Makeup Broad Spectrum SPF 25	OCTINOXATE, TITANIUM DIOXIDE	Merle Norman Cosmetics, Inc	552f6d2c-9b8c-aa52-e063-6294a90a787e	2026-06-26	Warnings	Exact identifier application number: M020
Bath and Body Works SPF Pink Pineapple Sunrise	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Bath & Body Works, Inc.	1c30a422-b22a-ca79-e063-6294a90a19a9	2026-06-26	Warnings	Exact identifier application number: M020
Bath and Body Works SPF Pink Pineapple Sunrise	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Bath & Body Works, Inc.	1c37a994-79dd-9720-e063-6294a90a7f34	2026-06-26	Warnings	Exact identifier application number: M020
Bath and Body Works SPF Waikiki Beach Coconut	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Bath & Body Works, Inc.	1c37b8d7-de72-f534-e063-6294a90aeab7	2026-06-26	Warnings	Exact identifier application number: M020
UV Daily Hydration Tinted	OCTISALAT AND ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc	02e71602-13e1-43b3-9cba-a75e46cccacc	2026-06-25	Warnings	Exact identifier application number: M020
Coral Isle SPF 50 Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Rocky Mountain	5515f562-62d9-c6ee-e063-6294a90a9ea6	2026-06-25	Warnings	Exact identifier application number: M020
SPF30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Zhejiang Ayan Biotech Co.,Ltd.	6759b9f7-296a-4c06-9198-b4e824e0bdc9	2026-06-25	Warnings	Exact identifier application number: M020
Delicate Beige Perfecting Makeup Broad Spectrum SPF 25	OCTINOXATE, TITANIUM DIOXIDE	Merle Norman Cosmetics, Inc	551928b4-74bb-3f6c-e063-6294a90a6b83	2026-06-25	Warnings	Exact identifier application number: M020
Alabaster Beige Perfecting Makeup Broad Spectrum SPF 25	OCTINOXATE, TITANIUM DIOXIDE	Merle Norman Cosmetics, Inc	5519290c-b040-6a37-e063-6394a90a8a1d	2026-06-25	Warnings	Exact identifier application number: M020
Soft Bisque Perfecting Makeup Broad Spectrum SPF 25	OCTINOXATE, TITANIUM DIOXIDE	Merle Norman Cosmetics, Inc	551ab7d1-dd2f-c6d8-e063-6394a90aff65	2026-06-25	Warnings	Exact identifier application number: M020
Alabaster Perfecting Makeup Broad Spectrum SPF 25	OCTINOXATE, TITANIUM DIOXIDE	Merle Norman Cosmetics, Inc	551b8c21-3afc-c804-e063-6294a90a5156	2026-06-25	Warnings	Exact identifier application number: M020
Scalp and Face Sunscreen Broad Spectrum SPF 30	ZINC OXIDE	Only Balds LLC	551bf10e-598c-1400-e063-6294a90a4af1	2026-06-25	Warnings	Exact identifier application number: M020
Bare Perfecting Makeup Broad Spectrum SPF 25	OCTINOXATE, TITANIUM DIOXIDE	Merle Norman Cosmetics, Inc	552f20b2-9a2e-70f3-e063-6394a90a9337	2026-06-25	Warnings	Exact identifier application number: M020
MORANDIPARK PANTHENOL ULTRA LIGHT SUNSCREEN	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	BRAND GENOME CO., Ltd.	51c07375-e81d-8572-e063-6394a90ab5b0	2026-06-24	Warnings	Exact identifier application number: M020
BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREEN	TITANIUM DIOXIDE	Shantou Woodsleep Biotechnology Co., Ltd.	54fc80b7-8f6c-e2be-e063-6394a90a4b59	2026-06-24	Warnings	Exact identifier application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	365613b6-36ec-0512-e063-6294a90a9532	2026-06-24	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	235a9430-b445-8d5c-e063-6394a90a9354	2026-06-24	Warnings	Exact identifier application number: M020
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	54ecaea7-dafe-9694-e063-6394a90ae3b5	2026-06-23	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