ULTRA VIOLETTE SPF ON THE GLOW- ultra violette spf on the glow - spf 50 duo pack kit 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]

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

ULTRA VIOLETTE SPF ON THE GLOW

Ultra Violette Preen Screen Broad Spectrum SPF 50

Ultra Violette Sheen Screen Broad Spectrum Hydrating Lip Balm Dusk

INGREDIENTS AND APPEARANCE

ULTRA VIOLETTE SPF ON THE GLOW 
ultra violette spf on the glow - spf 50 duo pack kit kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54394-111(NDC:54394-110)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54394-111-01	1 in 1 KIT; Type 0: Not a Combination Product	12/01/2025

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	0 BOTTLE, SPRAY	1 mL  in 30
Part 2	0 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 Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84803-101-30	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/01/2025

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 Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84803-104-02	15 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/01/2025

Labeler - Thermo-Pak Company, Inc. (079689440)