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 343 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm Ivory	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	97e7ece8-a705-4988-ba52-6d3f11573521	2021-12-01	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Chestnut	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	6a44f926-11b4-4bc4-8d5d-721a89c4f0cc	2021-11-09	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Hazelnut	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	b58af664-b0fd-4585-8417-7c20954d7aff	2021-11-09	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Umber	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	7bbd1334-fae8-4274-b927-a099af764345	2021-11-09	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cedar	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	970571f9-3d6b-46ae-a668-745de1911fa2	2021-11-09	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Wheat	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	542e1b2e-f63c-466b-b5ac-6c147a0e9dec	2021-11-08	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm Beige	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	21b65c12-6f67-4053-9508-6b2709cc1fb8	2021-11-08	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool Beige	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	8ea4c470-ebd5-448e-b72a-ccd1113de0ab	2021-11-08	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Honey	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	fd9689a4-21d1-49f0-bf59-b8e1da72cd16	2021-11-08	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Dune	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	c23b6a87-8cf9-4be3-8306-2285e7e926c1	2021-11-08	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Porcelain	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	a93cb6c6-d7c2-43cc-a2e8-961f896a977e	2021-11-08	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Latte	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	32d99955-1593-426b-958e-5dcf689192a3	2021-11-08	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Tawny	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	762deb57-754b-46a9-9907-de05e11da178	2021-11-08	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Amber	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	3b5366e4-180a-4b98-9524-63601ae9d270	2021-11-08	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool Vanilla	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	9a0ab557-e1f3-4c89-a9ae-0f81fbc5032e	2021-11-04	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Calico	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	3e67abb5-84a4-4a78-9ea3-9fd57cbeb482	2021-11-04	Warnings	Exact identifier application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool Ivory	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	477d79c1-f169-4d0e-a95d-f5e832855f0d	2021-11-04	Warnings	Exact identifier application number: M020
Anhydrous SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Owen Biosciences, Inc.	1510cae2-9c8f-45ba-b088-67747af3d30c	2021-07-15	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Tawny	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	3f0480e4-b2c3-962c-e063-6294a90a4f23	2021-07-13	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cool Ivory	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	aa708db4-ad90-49b7-a250-5698e4c7d3d6	2021-07-13	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