FDA.reportPublic FDA data

Sheen Screen - Bejewelled

Manufacturer
Grace And Fire USA Inc.
Effective date
2026-10-01
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-09-01 13:03:15

Label at a glance#

ProductUltra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Bejewelled
Active ingredientAVOBENZONE, OCTINOXATE, OCTOCRYLENE
Label structure10 sections

Indications and uses

- Helps Prevent Sunburn - if used as directed with other sun protection measures ( see Directions) ,decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

* Apply liberally 15 minutes before sun exposure * Reapply at least every 2 hours • Use a water resistant sunscreen if swimming or sweating * Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging To decrease this risk, regularly use a sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sun protection measures including: * Limit time in the sun, es...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Octinoxate 5%

Octocrylene 4.7%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

- Helps Prevent Sunburn

- if used as directed with other sun protection measures ( see Directions) ,decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For External use Only

Do not use

- on damaged or broken skin, when using this product

- keep out of eyes rinse with water to remove

Stop use and ask doctor if

OTC - STOP USE SECTION

- rash occur

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

if swallowed , call a poison control centre or get medical help right away

Directions

DOSAGE & ADMINISTRATION SECTION

* Apply liberally 15 minutes before sun exposure
* Reapply at least every 2 hours • Use a water resistant sunscreen if swimming or sweating
* Sun Protection
Measures. Spending time in the sun increases your risk of skin cancer and early skin aging

To decrease this risk, regularly use a sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sun protection measures including:
* Limit time in the sun, especially from 10a.m.- 2p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses • Children under 6 months of age: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Lanolin, Theobroma Cacao (Cocoa) Seed Butter, Cera Alba, Ricinus Communis (Castor) Seed Oil, Butyrospermum Parkii (Shea)
Butter, Helianthus Annuus (Sunflower) Seed Oil, Olea Europaea (Olive) Fruit Oil, Flavour, Caprylic/Capric Triglyceride, Calcium Sodium Borosilicate, Tocopherol, Silica, Myrothamnus Flabellifolia Leaf/Stem Extract, BHT, Limonene, Vanillin, Mentha Piperta Oil, Menthol, Titanium Dioxide (CI 77891), Mica, Iron Oxides (CI 77491), Red 30 Lake (CI 73360, Blue 1 Lake (CI 42090), Red 7 Lake (CI 15850), Tin Oxide

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ULTRA VIOLETTE

SHEEN

SCREEN

SPF 50

Hydrating Lip Balm

The Ultimate

Everyday

Lip Protector

BEJEWELLED

Broad Spectrum SPF 50

15g 0.5oz

PDPPDP

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84803-10584803-105-01, 84803-105-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTOCRYLENE5A68WGF6WMACTIB
TOCOPHEROLR0ZB2556P8IACT
D&C RED NO. 7ECW0LZ41X8IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
MICAV8A1AW0880IACT
RICINUS COMMUNIS (CASTOR) SEED OILD5340Y2I9GIACT
OLEA EUROPAEA (OLIVE) FRUIT OIL6UYK2W1W1EIACT
CI 774911K09F3G675IACT
WHITE WAX7G1J5DA97FIACT
THEOBROMA CACAO (COCOA) SEED BUTTER512OYT1CRRIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
LANOLIN7EV65EAW6HIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL3W1JG795YIIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
MYROTHAMNUS FLABELLIFOLIA TOPJ65B6VMC9DIACT
BHT1P9D0Z171KIACT
LIMONENE, (+)-GFD7C86Q1WIACT
VANILLINCHI530446XIACT
MENTHA PIPERITA (PEPPERMINT) OILAV092KU4JHIACT
MENTHOLL7T10EIP3AIACT
CI 733602S42T2808BIACT
CI 42090H3R47K3TBDIACT
TIN OXIDEKM7N50LOS6IACT
CALCIUM SODIUM BOROSILICATE4MM76N4WMYIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42026-01-06full-release2026-06-01 01:31:27
32025-12-11monthly-update2026-06-03 17:45:48

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm BejewelledSPF50Grace And Fire USA Inc.274a0544-6c71-4d91-e063-6394a90a22472026-10-01WarningsExact identifier
ndc (package): 84803-105-02
ndc (package): 84803-105-01
ndc (product): 84803-105
ndc11 (package): 84803010502
ndc11 (package): 84803010501
spl id: 5a0eed9c-da27-5b38-e063-6294a90a2cad
spl set id: 274a0544-6c71-4d91-e063-6394a90a2247

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.