Ultra Violette Supreme Screen Broad Spectrum SPF 50

Product NDC: 84803-100
11-digit product format: 848030100
Labeler code: 84803
Product ID: 84803-100_561cbb3d-11b5-8bce-e063-6294a90a871d
Type: HUMAN OTC DRUG
Nonproprietary name: AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE
Dosage form: CREAM
Route: TOPICAL
Labeler: Grace and Fire USA Inc.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-12-01
Substance: HOMOSALATE; AVOBENZONE; OCTISALATE; OCTOCRYLENE
Active strength: 70; 30; 50; 80 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 Supreme Screen Broad Spectrum SPF 50
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HOMOSALATE	70 mg/mL
AVOBENZONE	30 mg/mL
OCTISALATE	50 mg/mL
OCTOCRYLENE	80 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V06SV4M95S	Internal UNII lookup
G63QQF2NOX	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
5A68WGF6WM	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
24389324-19db-7eb5-e063-6394a90ad7fb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99	Product name	1	20250618
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84803-100-05	Ultra Violette Supreme Screen Broad Spectrum SPF 50	5 mL in 1 TUBE	CREAM	5		6
84803-100-15	Ultra Violette Supreme Screen Broad Spectrum SPF 50	15 mL in 1 TUBE	CREAM	15		6
84803-100-20	Ultra Violette Supreme Screen Broad Spectrum SPF 50	20 mL in 1 BOTTLE, PLASTIC	CREAM	20		6
84803-100-21	Ultra Violette Supreme Screen Broad Spectrum SPF 50	20 mL in 1 BOTTLE, PUMP	CREAM	20		6
84803-100-50	Ultra Violette Supreme Screen Broad Spectrum SPF 50	50 mL in 1 TUBE	CREAM	50		6
84803-100-15	Ultra Violette Mini MatesDuo Pack	15 mL in 1 TUBE	CREAM	1 mL in 15	8 g in 100mL	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84803-100	ULTRA VIOLETTE SUPREME SCREEN BROAD SPECTRUM SPF 50 (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) CREAM [GRACE AND FIRE USA INC.]	3	Current NDC, 5 package rows	20241202_24389324-19db-7eb5-e063-6394a90ad7fb.zip
84803-100	ULTRA VIOLETTE MINI MATES DUO PACK (SPF 50) KIT [GRACE AND FIRE USA INC.]	2	Current NDC	20241231_27e377c2-1e68-d4e2-e063-6394a90a2812.zip
84803-100	ULTRA VIOLETTE MINI MATES DUO PACK (SPF 50) KIT [THERMO-PAK COMPANY, INC.]	1	Current NDC	20241231_2a54ed65-12d5-8a96-e063-6394a90a6e02.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 157 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alba Botanica Sensitive Mineral SPF 50	ZINC OXIDE	The Hain Celestial Group, Inc.	4484b16f-f29a-60cc-e063-6294a90a2b9d	2025-11-26	Warnings	Exact identifier application number: M020
Alba Botanica Sheer Mineral SPF50	ZINC OXIDE	The Hain Celestial Group, Inc.	0cf9c4b9-8e85-980c-e063-6394a90a9e7e	2025-11-26	Warnings	Exact identifier application number: M020
Alba Botanica Sensitive Mineral SPF 30	ZINC OXIDE	The Hain Celestial Group, Inc.	44867882-d9c1-7389-e063-6294a90a7f77	2025-11-26	Warnings	Exact identifier application number: M020
Alba Botanica Sheer Mineral SPF30	ZINC OXIDE	The Hain Celestial Group, Inc.	0cf9361f-f292-6429-e063-6294a90add0e	2025-11-26	Warnings	Exact identifier application number: M020
ZO Skin Health Gel Sunscreen Broad-Spectrum SPF 50	AVOBENZONE, OCTISALATE, OCTOCRYLENE	ZO Skin Health, Inc.	ec8386f2-9cb7-40f4-e053-2995a90ac2d8	2025-11-26	Warnings	Exact identifier application number: M020
WOODSLEEP Tallow Sunscreen	TITANIUM DIOXIDE	Shantou Woodsleep Biotechnology Co., Ltd.	330a9f2e-7ce1-f83f-e063-6394a90a184a	2025-11-26	Warnings	Exact identifier application number: M020
WOODSLEEP Tallow Sunscreen	TITANIUM DIOXIDE	Shantou Woodsleep Biotechnology Co., Ltd.	33cdde09-e7ee-e003-e063-6394a90a8762	2025-11-26	Warnings	Exact identifier application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Tropical Breeze Broad Spectrum SPF 30	ZINC OXIDE	The Procter & Gamble Manufacturing Company	44718c3c-b081-bcfb-e063-6394a90a3786	2025-11-25	Warnings	Exact identifier application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Unscented Broad Spectrum SPF 30	ZINC OXIDE	The Procter & Gamble Manufacturing Company	4472cc1e-6b34-388b-e063-6394a90ac7b6	2025-11-25	Warnings	Exact identifier application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Pear and Coconut Water Broad Spectrum SPF 30	ZINC OXIDE	The Procter & Gamble Manufacturing Company	4472ef69-8992-fcab-e063-6294a90a6b90	2025-11-25	Warnings	Exact identifier application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Vanilla Milk and Shea Broad Spectrum SPF 30	ZINC OXIDE	The Procter & Gamble Manufacturing Company	44732f89-8ac3-8c5d-e063-6394a90aba73	2025-11-25	Warnings	Exact identifier application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Unscented Broad Spectrum SPF 30	ZINC OXIDE	The Procter & Gamble Manufacturing Company	447347d6-b8a3-7338-e063-6294a90abbf9	2025-11-25	Warnings	Exact identifier application number: M020
Native Mineral Suncare Zinc Oxide Sunscreen Pear and Coconut Water Broad Spectrum SPF 30	ZINC OXIDE	The Procter & Gamble Manufacturing Company	4473c4cc-f8b5-4a92-e063-6394a90ae690	2025-11-25	Warnings	Exact identifier application number: M020
salmon colored sunscreen	SALMON COLORED SUNSCREEN	Guangzhou Fantesy Biotechnology Co.,Ltd	4477964b-28f3-a371-e063-6294a90a4230	2025-11-25	Warnings	Exact identifier application number: M020
Safe Sea SPF 50 Mineral	ZINC OXIDE	Nidaria Technology Ltd.	f6cf9454-552b-486e-a38b-ab3c183b24a1	2025-11-24	Warnings	Exact identifier application number: M020
Safe Sea SPF 30	ZINC OXIDE	Nidaria Technology Ltd.	91bf07ed-0be4-43c9-b5f3-4e8eb892bca5	2025-11-24	Warnings	Exact identifier application number: M020
Olay Complete UV365 Daily Moisturizer Sensitive Broad Spectrum SPF 15	OCTINOXATE AND ZINC OXIDE	The Procter & Gamble Manufacturing Company	5904baa8-3070-1d77-e053-2a91aa0a6852	2025-11-24	Warnings	Exact identifier application number: M020
it cosmetics Bye Bye Foundation Full Coverage Moisturizer with 3D Skin Flex Broad Spectrum SPF 50 Plus UVA UVB Physical Sunscreen All Shades	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA, Inc.	86eea4df-4191-4e05-9f05-4a98ef8c2a4d	2025-11-24	Warnings	Exact identifier application number: M020
Cetaphil Sun Tinted Face SPF 40	TITANIUM DIOXIDE, ZINC OXIDE	Galderma Laboratories, L.P.	22413f93-7219-4726-b741-2392e576b34a	2025-11-24	Warnings	Exact identifier application number: M020
VEIL MINERAL PRIMER SUNSCREEN BROAD SPECTRUM SPF 15	ZINC OXIDE AND TITANIUM DIOXIDE	Kingdom Animalia, LLC DBA Hourglass Cosmetics	28e23498-953f-47c0-838c-bbf0e858d903	2025-11-24	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84803-100-05	84803010005	5 mL in 1 TUBE (84803-100-05)	5 ml	2024-12-01	No	No	Current
84803-100-10	84803010010	100 mL in 1 BOTTLE (84803-100-10)	100 ml	2026-07-08	No	No	Current
84803-100-15	84803010015	15 mL in 1 TUBE (84803-100-15)	15 ml	2024-12-01	No	No	Current
84803-100-20	84803010020	20 mL in 1 BOTTLE, PLASTIC (84803-100-20)	20 ml	2024-12-01	No	No	Current
84803-100-21	84803010021	20 mL in 1 BOTTLE, PUMP	20 ml				Historical
84803-100-50	84803010050	50 mL in 1 TUBE (84803-100-50)	50 ml	2024-12-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Supreme Screen SPF 50	Grace and Fire USA Inc.	2026-07-08	HUMAN OTC DRUG LABEL	9
Ultra Violette Mini Mates Duo Pack	Grace And Fire USA Inc.	2026-03-25	HUMAN OTC DRUG LABEL	5
Ultra Violette Mini Mates Duo Pack	Thermo-Pak Company, Inc.	2024-12-28	HUMAN OTC DRUG LABEL	1