ULTRA VIOLETTE SPF ON THE GLOW - SPF 50 Duo Pack Kit

ULTRA VIOLETTE SPF ON THE GLOW by

Drug Labeling and Warnings

ULTRA VIOLETTE SPF ON THE GLOW by is a Otc medication manufactured, distributed, or labeled by Thermo-Pak Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ULTRA VIOLETTE SPF ON THE GLOW- ultra violette spf on the glow - spf 50 duo pack kit 
Thermo-Pak Company, Inc.

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ULTRA VIOLETTE SPF ON THE GLOW - SPF 50 Duo Pack Kit

Active Ingredients

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

Sunscreen

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

Warnings

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

rash occur

Keep out of reach of children

Keep out of reach of children

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

Directions

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

Protect this product from excessive heat and direct sun

Inactive ingreidnts

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

2510-aaaULTRA VIOLETTE SPF ON THE GLOW

Ultra Violette Preen Screen Broad Spectrum SPF 50

Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk

ULTRA VIOLETTE SPF ON THE GLOW 
ultra violette spf on the glow - spf 50 duo pack kit kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 54394-111(NDC: 54394-110)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 54394-111-011 in 1 KIT; Type 0: Not a Combination Product12/01/202512/01/2025
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 10 BOTTLE, SPRAY 1 mL  in 30 
Part 20 TUBE 1 g  in 15 
Part 1 of 2
ULTRA VIOLETTE PREEN SCREEN BROAD SPECTRUM SPF 50 
avonbenzone,homosalate,octisalate,octocrylene spray
Product Information
Item Code (Source)NDC: 84803-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE60 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)  
SODIUM HYALURONATE (UNII: YSE9PPT4TH)  
BISABOLOL (UNII: 24WE03BX2T)  
GLYCINE SOJA (SOYBEAN) SEED (UNII: L7HT8F1ZOD)  
ACRYLATES/OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)  
NIACINAMIDE (UNII: 25X51I8RD4)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
LINALOOL (UNII: D81QY6I88E)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
ISODODECANE (UNII: A8289P68Y2)  
FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HEXYL CINNAMAL (UNII: 7X6O37OK2I)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALCOHOL (UNII: 3K9958V90M)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 84803-101-3030 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/01/2025
Part 2 of 2
ULTRA VIOLETTE SHEEN SCREEN BROAD SPECTRUM HYDRATING LIP BALM DUSK 
spf50 ointment
Product Information
Item Code (Source)NDC: 84803-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4.7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)  
LANOLIN (UNII: 7EV65EAW6H)  
CI 77491 (UNII: 1K09F3G675)  
MYROTHAMNUS FLABELLIFOLIA TOP (UNII: J65B6VMC9D)  
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)  
RICINUS COMMUNIS (CASTOR) SEED OIL (UNII: D5340Y2I9G)  
OLEA EUROPAEA (OLIVE) FRUIT OIL (UNII: 6UYK2W1W1E)  
THEOBROMA CACAO (COCOA) SEED BUTTER (UNII: 512OYT1CRR)  
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)  
WHITE WAX (UNII: 7G1J5DA97F)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 84803-104-0215 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/01/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/01/202512/01/2025
Labeler - Thermo-Pak Company, Inc. (079689440)

Revised: 1/2026