ULTRA VIOLETTE MINI MATES DUO PACK- spf 50 kit

Ultra Violette Mini Mates by

Drug Labeling and Warnings

Ultra Violette Mini Mates 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

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 MINI MATES  DUO PACK
spf 50 kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54394-110(NDC:84803-110)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54394-110-01	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	11/29/2024

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	0 TUBE	1 mL  in 15
Part 2	0 TUBE	1 mL  in 15

Part 1 of 2

ULTRA VIOLETTE VELVET SCREEN BLURRING MINERAL SKINSCREEN 
spf50 cream

Product Information
Item Code (Source)	NDC: 84803-106
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	22.75 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
2-ACETAMIDO-2-DEOXY-D-GLUCONO-1,5-LACTONE (UNII: 09ICI1V6AX)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
CITRIC ACID ACETATE (UNII: DSO12WL7AU)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
XANTHAN GUM (UNII: TTV12P4NEE)
ISOSTEARIC ACID (UNII: X33R8U0062)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERIN (UNII: PDC6A3C0OX)
CI 77499 (UNII: XM0M87F357)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
CI 77491 (UNII: 1K09F3G675)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
CI 77492 (UNII: EX438O2MRT)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84803-106-01	15 mL 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

Part 2 of 2

ULTRA VIOLETTE SUPREME SCREEN BROAD SPECTRUM SPF 50 
avobenzone,homosalate,octisalate,octocrylene cream

Product Information
Item Code (Source)	NDC: 84803-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
TROLAMINE (UNII: 9O3K93S3TK)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
LACTIC ACID (UNII: 33X04XA5AT)
CARNAUBA WAX (UNII: R12CBM0EIZ)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SQUALANE (UNII: GW89575KF9)
CI 77492 (UNII: EX438O2MRT)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CARNOSINE (UNII: 8HO6PVN24W)
PEG-40 MONOSTEARATE (UNII: ECU18C66Q7)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
RICE BRAN (UNII: R60QEP13IC)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
ISODODECANE (UNII: A8289P68Y2)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
NYLON-12 (UNII: 446U8J075B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84803-100-15	15 mL 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 - Thermo-Pak Company, Inc. (079689440)