Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk

Product NDC: 84803-104
11-digit product format: 848030104
Labeler code: 84803
Product ID: 84803-104_5a0e9ed0-8900-f1b7-e063-6394a90abe9f
Type: HUMAN OTC DRUG
Nonproprietary name: spf50
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Grace And Fire USA Inc.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-12-01
Substance: OCTINOXATE; AVOBENZONE; OCTOCRYLENE
Active strength: 5; 3; 4.7 g/100g; g/100g; g/100g
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 Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTINOXATE	5 g/100g
AVOBENZONE	3 g/100g
OCTOCRYLENE	4.7 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4Y5P7MUD51	Internal UNII lookup
G63QQF2NOX	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
2735ab0f-5eec-04c5-e063-6394a90aa60e	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84803-104-01	Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk	7 g in 1 TUBE	OINTMENT	7		4
84803-104-02	Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk	15 g in 1 TUBE	OINTMENT	15		4
84803-104-02	ULTRA VIOLETTE SPF ON THE GLOWDuo Pack Kit	15 g in 1 TUBE	OINTMENT	1 g in 15	3 g in 100g	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84803-104	ULTRA VIOLETTE SHEEN SCREEN BROAD SPECTRUM HYDRATING LIP BALM DUSK (SPF50) OINTMENT [GRACE AND FIRE USA INC.]	2	Current NDC, 2 package rows	20250227_2735ab0f-5eec-04c5-e063-6394a90aa60e.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 163 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sunsovle MD Volumize and Restore	ZINC OXIDE	Sunsolve MD Inc	26f3cdda-b990-15cb-e063-6394a90ade29	2025-11-14	Warnings	Exact identifier application number: M020
Naturium Dew-Glow Moisturizer SPF 50	HOMOSALATE, OCTISALATE, AVOBENZONE	e.l.f. Cosmetics, Inc	0a5b80fb-caeb-eb56-e063-6294a90a238b	2025-11-14	Warnings	Exact identifier application number: M020
Naturium Dew Glow Tinted Moisturizer SPF50	HOMOSALATE, OCTISALATE, AVOBENZONE	e.l.f. Cosmetics, Inc.	0d82f310-f87a-f76d-e063-6294a90af251	2025-11-14	Warnings	Exact identifier application number: M020
Naturium Dew Glow Tinted Moisturizer SPF50-deep	HOMOSALATE, OCTISALATE, AVOBENZONE	e.l.f. Cosmetics, Inc.	0d865e74-1baf-6a44-e063-6394a90a37ac	2025-11-14	Warnings	Exact identifier application number: M020
Naturium Dew Glow Tinted Moisturizer SPF50-medium	HOMOSALATE, OCTISALATE, AVOBENZONE	e.l.f. Cosmetics, Inc.	0d8616a8-2eab-c85c-e063-6294a90a3984	2025-11-14	Warnings	Exact identifier application number: M020
Naturium UV Reflect Antioxidant SPF 50	HOMOSALATE, OCTISALATE, AVOBENZONE	e.l.f. Cosmetics, Inc	0a5c6fc8-6cdc-0ae5-e063-6394a90ae01c	2025-11-14	Warnings	Exact identifier application number: M020
CERAVE DEVELOPED WITH DERMOTOLOGISTS Invisible Mineral Sunscreen FOR ALL SKIN TYPES AND TONES FACE UVB AND UVA BROAD SPECTRUM SPF 50	TITANIUM DIOXIDE AND ZINC OXIDE	LOreal USA Products Inc	372894af-bed7-474f-95d4-69a8c3f215ef	2025-11-14	Warnings	Exact identifier application number: M020
HEIMISH RX HYALURONIC ACID HYDRATING SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	ONEAND CO., LTD.	2dc41560-f4a7-5f0b-e063-6294a90a0630	2025-11-13	Warnings	Exact identifier application number: M020
Covey Sun and Done Daily Moisturizing	ZINC OXIDE	Covey Skin	fbcf8204-0673-99aa-e053-6294a90ac26e	2025-11-13	Warnings	Exact identifier application number: M020
SOL Science The Fifty	ZINC OXIDE	Beauty Pie	01548858-8b0e-494a-e063-6294a90a8e99	2025-11-13	Warnings	Exact identifier application number: M020
Balmere Mineral Sunscreen Moisturizer Primer	ZINC OXIDE	Balmere	00d813e0-eb97-a6ba-e063-6394a90aa525	2025-11-13	Warnings	Exact identifier application number: M020
Dove Clinical Care	96H PROTECTION FRESH PEACH DRY SPRAY ANTIPERSPIRANT DEODORANT	Conopco d/b/a Unilever	437eb2a8-428c-8339-e063-6394a90a74b2	2025-11-13	Warnings	Exact identifier application number: M020
Dove Clinical Care	96H PROTECTION ORIGINAL CLEAN DRY SPRAY ANTIPERSPIRANT DEODORANT	Conopco d/b/a Unilever	437f4db5-552f-1550-e063-6394a90aaedb	2025-11-13	Warnings	Exact identifier application number: M020
Depology Essential Mineral UV Care	ZINC OXIDE	Depology Holdings LLC	1d48cdee-be67-14c0-e063-6294a90a7422	2025-11-13	Warnings	Exact identifier application number: M020
Hanalei Face Moisturizing	ZINC OXIDE	Hanalei Beauty Company LLC	1f7c1a68-5aea-0deb-e063-6394a90a3a43	2025-11-13	Warnings	Exact identifier application number: M020
Glo Skin	TITANIUM DIOXIDE, ZINC OXIDE	Glo Skin Beauty	f4bed574-68c1-0d2c-e053-2a95a90a15ff	2025-11-13	Warnings	Exact identifier application number: M020
Dove Clinical Care	96H PROTECTION SOFT SENSITIVE DRY SPRAY ANTIPERSPIRANT DEODORANT	Conopco d/b/a Unilever	4380036a-7698-03e7-e063-6294a90a7301	2025-11-13	Warnings	Exact identifier application number: M020
SOME BY MI V10 HYAL AIR FIT SUNSCREEN	SUNSCREENT	PERENNEBELL	fe2148db-9020-9343-e053-6294a90adf70	2025-11-13	Warnings	Exact identifier application number: M020
skin MD	OCTINOXATE, OCTISALATE, HOMOSALATE	21st Century Formulations	e809e1d3-0a6d-730d-e053-2a95a90aedb9	2025-11-13	Warnings	Exact identifier application number: M020
Obagi Nu-Derm Fx System Normal-Oily Skin Transformation Complexion Brightening System	TITANIUM DIOXIDE, ZINC OXIDE	Obagi Cosmeceuticals LLC	a64045dd-8f70-43f1-be6f-ad1556c0e210	2025-11-13	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
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
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
84803-104-01	84803010401	7 g in 1 TUBE (84803-104-01)	7 g	2024-12-01	No	No	Current
84803-104-02	84803010402	15 g in 1 TUBE (84803-104-02)	15 g	2024-12-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sheen Screen - Dusk	Grace And Fire USA Inc.	2026-10-01	HUMAN OTC DRUG LABEL	5
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