ULTRA VIOLETTE SPF ON THE GLOW

Manufacturer
Thermo-Pak Company, Inc.
Effective date
2025-11-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:34:17

Label at a glance#

ProductULTRA VIOLETTE SPF ON THE GLOW
Active ingredientAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, OCTINOXATE
Label structure10 sections

Indications and uses

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

Directions  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...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

ULTRA VIOLETTE SPF on the glow Duo Kit

Sheen Screen SPF 50 Hydreating Lip Blam Dusk 15g

AVOBENZONE 3.0%

OCTINOXATE 5.0%

OCTOCRYLENE 4.7%

Sreen Screen SPF 50 Reapplication Mist Skinscreen 30mL

AVOBENZONE 3.0%

HOMOSALATE 10.0%

OCTISALATE 5.0%

OCTOCRYLENE 6.0%

PURPOSE SECTION

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

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 IF

OTC - STOP USE SECTION

rash occur

Keep out of reach of children

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

Directions
 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

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun

Inactive ingreidnts

INACTIVE INGREDIENT SECTION

Ultra Violette Preen Screen SPF 50

Alcohol, Diisopropyl Adipeate, lsododecane, Acrylates/ Octylaaylamide Copolymer, Bisabolol,, Niacinamide, Tocopheryl Acetale, Ascorbyl Tetraisopalmitate, Camellia Slnensls Leaf Extract, Aloe Barbadensis Leaf Extract, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunlower) Seed Oil, Sodium Hyaluronate, TocopheroI, Silica Dimethylsilylate, Butylene Glucol, Phenoxyethanol, Ethylhexyl palmitate, Caprylyl Glycol, Hexylene Glycol, Fragrance, Benzyl Salicylate, Hexyl Cinnamal, Linalool

Ultra Violette Sheen Screen SPF 50

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, Tocopherol, Myrothamnus Flabellifolia Leaf/Stem Extract, Titanium Dioxide (Cl 77891), Iron Oxide Red (CI 77491).

PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2510-aaa2510-aaaULTRA VIOLETTE SPF ON THE GLOW

Ultra Violette Preen Screen Broad Spectrum SPF 50

Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk

Products#

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

DailyMed product names page 1 of 2 · 46 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54394-11154394-111-01
54394-110
84803-10184803-101-30
84803-10484803-104-02

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 43 matching rows.

Source Document#

Source XML

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm DuskSPF50Grace And Fire USA Inc.2735ab0f-5eec-04c5-e063-6394a90aa60e2026-10-01WarningsExact identifier
ndc (package): 84803-104-02
ndc (product): 84803-104
ndc11 (package): 84803010402
Ultra Violette Preen Screen Broad Spectrum SPF 50AVONBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEGrace and Fire USA Inc.26a0fc0d-a903-2ac1-e063-6394a90a13db2026-06-01WarningsExact identifier
ndc (package): 84803-101-30
ndc (product): 84803-101
ndc11 (package): 84803010130
47b69602-8930-32ee-e063-6394a90a54ff42b3b21e-40a2-c0cf-e063-6394a90ab5512026-01-06WarningsExact identifier
spl set id: 42b3b21e-40a2-c0cf-e063-6394a90ab551
ULTRA VIOLETTE SPF ON THE GLOW Duo Pack KitSPF 50Grace And Fire USA Inc.47b7da8a-ea89-1402-e063-6294a90a23f92026-01-06WarningsExact identifier
ndc (package): 84803-101-30
ndc (package): 84803-104-02
ndc11 (package): 84803010402
ndc11 (package): 84803010130

Reported adverse events (FAERS/openFDA)#

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