ULTRA VIOLETTE SPF ON THE GLOW

Manufacturer
Grace And Fire USA Inc.
Effective date
2026-01-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:32:33

Label at a glance#

ProductULTRA VIOLETTE SPF ON THE GLOW Duo Pack Kit
Active ingredientOCTISALATE, OCTOCRYLENE, HOMOSALATE, AVOBENZONE, 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

ACTIVE INGREDIENTS : VELVET SCREEN SPF 50

ZINC OXIDE 22.75%

ACTIVE INGRDIENTS : SUPREME SCREEN SPF 50

Avobenzone 3%

Homosalate 7%

Octisalate 5%

Octocrylene 8%

Purpose

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 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

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients : VELVET SCREEN SPF
Water, Coco-Caprylate/Caprate,
Octyldodecanol, Caprylic/Capric
Triglyceride, PEG-30
Dipolyhydroxystearate, Glycerin,
Polyglyceryl-3 Polyricinoleate,
Cetearyl Glucoside, Cetearyl Alcohol,
Gluconolactone, Isostearic Acid,
Sodium Chloride, Saccharide
Isomerate, Sodium Benzoate,
Xanthan Gum, Disodium EDTA,
Terminalia Ferdinandiana (Kakadu
Plum) Fruit Extract, Calcium
Gluconate, Citric Acid, Ammonium
Acryloyldimethyltaurate/VP
Copolymer, Sodium Citrate, Iron
Oxides (CI77492), Iron Oxides
(CI77491), Iron Oxides (CI77499).

Inactive Ingredients : SUPREME SCREEN SPF 50
Water, Alcohol Denat., Butylene Glycol, Diisopropyl Adipate, Glycerin, Cetearyl Alcohol, Caprylyl Methicone, Isododecane, Copernicia Cerifera (Camauba) Wax, Oryza Sativa (Rice) Bran Wax, Polysorbale 60, Dimethicone, Ceteareth-20, Nylon-6/12, Saccharide Isamerate, Squalane, Camosine, Tocopheryl Acetate, Terminalia Ferdinandiana (Kakadu Plum) Fruit Extract, Silica, PEG-40 Stearate, Citric Acid, Hydroxyelnyl Acrlale/Sodiumm
Acryloyloimelnyl Taurale Copolymer, Glyceryl Capryllate, Fragrance, Disodium EDTA, Pentylene Clyool, Caprylhydraxamio Acid,
Triethanolamino, Laotic Aoid, Sorbitan Isostearate, Sodium Citrate, Iron Oxides (C| 77491), Iron Oxides (C|77492), Iron Oxides (C| 77499).

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun

Broad Spectrum SPF 50
Sunscreen PA++++
15ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84803-101-30ULTRA VIOLETTE SPF ON THE GLOWDuo Pack Kit30 mL in 1 BOTTLE, SPRAYSPRAY1 mL in 3030 mg in 1mL4
84803-104-02ULTRA VIOLETTE SPF ON THE GLOWDuo Pack Kit15 g in 1 TUBEOINTMENT1 g in 153 g in 100g4
84803-111-01ULTRA VIOLETTE SPF ON THE GLOWDuo Pack Kit1 in 1 KITKIT14

Products#

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

DailyMed product names page 1 of 2 · 45 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84803-11184803-111-01
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 · 41 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 · 3 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
ULTRA VIOLETTE SPF ON THE GLOW Duo Pack KitSPF 50Grace And Fire USA Inc.47b7da8a-ea89-1402-e063-6294a90a23f92026-01-06WarningsExact identifier
ndc (package): 84803-111-01
ndc (package): 84803-101-30
ndc (package): 84803-104-02
ndc (product): 84803-111
ndc11 (package): 84803011101
ndc11 (package): 84803010402
ndc11 (package): 84803010130
spl id: 47b7dab4-2800-9cda-e063-6394a90a24da
spl set id: 47b7da8a-ea89-1402-e063-6294a90a23f9

Reported adverse events (FAERS/openFDA)#

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