ULTRA VIOLETTE SPF ON THE GLOW DUO PACK KIT- spf 50 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 Grace And Fire USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

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

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 and ask doctor 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

Inactive Ingredients

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

Protect this product from excessive heat and direct sun

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTRA VIOLETTE SPF ON THE GLOW  DUO PACK KIT
spf 50 kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84803-111

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84803-111-01	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	01/01/2026

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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	60 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ISODODECANE (UNII: A8289P68Y2)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
HELIANTHUS ANNUUS (SUNFLOWER) SEED (UNII: R9N3379M4Z)
ALCOHOL (UNII: 3K9958V90M)
ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
LINALOOL, (-)- (UNII: 3U21E3V8I2)
CAMELLIA SINENSIS LEAF OIL (UNII: VC855RRT77)
NIACINAMIDE (UNII: 25X51I8RD4)
GLYCINE MAX (SOYBEAN) OIL (UNII: 241ATL177A)
HEXYL CINNAMAL (UNII: 7X6O37OK2I)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BISABOLOL (UNII: 24WE03BX2T)
ACRYLATES/OCTYLACRYLAMIDE COPOLYMER (40000 MW) (UNII: 7LL6SY9YFV)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)

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	12/01/2024

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
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
CI 77491 (UNII: 1K09F3G675)
RICINUS COMMUNIS (CASTOR) SEED OIL (UNII: D5340Y2I9G)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WHITE WAX (UNII: 7G1J5DA97F)
MYROTHAMNUS FLABELLIFOLIA TOP (UNII: J65B6VMC9D)
THEOBROMA CACAO (COCOA) SEED BUTTER (UNII: 512OYT1CRR)
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)
LANOLIN (UNII: 7EV65EAW6H)
OLEA EUROPAEA (OLIVE) FRUIT OIL (UNII: 6UYK2W1W1E)

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	12/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/29/2024

Labeler - Grace And Fire USA Inc. (119357605)