NOON POST PROCEDURE PROGRAM- allantoin, titanium dioxide, octocrylene, and avobenzone kit

NOON Post Procedure Program by

Drug Labeling and Warnings

NOON Post Procedure Program by is a Otc medication manufactured, distributed, or labeled by Noon Aesthetics M.R. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DeFlame + DERMSHIELD™

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Allantoin 0.5%

Purpose

Skin Protectant

Uses

• Temporarily protects minor: skin irritation, cuts, scrapes, burns and helps protect and relieve chafed, chapped or cracked skin.

Warnings

For external use only.

Do not use on

• deep or puncture wounds, animal bites, serious burns.

When using this product

• avoid contact with eyes. In case of eye contact, flush with water.

Stop use and ask a doctor if

• condition worsens.
• symptoms last more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

Directions

• Apply as needed.

Inactive Ingredients

Water, Propylene Glycol, Glycerin, Dimethyl Sulfone, Strontium Chloride Hexahydrate, Dimethicone, Cetyl Alcohol, Glyceryl Stearate, Propanediol, Dipotassium Glycyrrhizate, Polysorbate 20, PEG-40 Stearate, Laureth-4, Porphyridium Cruentum Extract, Arnica Montana Flower Extract, sh-Oligopeptide-1 (EGF), sh-Oligopeptide-2 (IGF-1), sh-Polypeptide-1 (bFGF), sh-Polypeptide-9 (VEGF), sh-Polypeptide-11 (FGF-1), Bacillus/Folic Acid Ferment Filtrate Extract, Octyldodecyl Xyloside, Butylene Glycol, Sodium Hyaluronate, 1,2-Hexanediol, Acetyl Glutamine, Octyldodecanol, PEG-30 Dipolyhydroxystearate, Sorbitan Tristearate, Lecithin, Phenoxyethanol, Benzyl Alcohol, Caprylyl Glycol, Potassium Sorbate, Disodium EDTA, Sodium Benzoate.

SPL UNCLASSIFIED SECTION

Multi-Vit Sun Protector SPF 30

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredient	Purpose
Titanium Dioxide 9%	Sunscreen
Octocrylene 4.8%	Sunscreen
Butyl Methoxydibenzoylmethane 1.44%	Sunscreen

Uses

• Help prevent sunburn.

Warnings

For external use only.

Do not use

• on damage or broken skin.

When using this product

• keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor

• if rash or irritation develops and lasts.

Keep out of reach of children.

• If product is swallowed, get medical help or contact a poison control center right away.

Directions

• Apply liberally 15 minutes before sun exposure and as needed.
• Use a water-resistant sunscreen if swimming or sweating.
• Reapply at least every 2 hours.
• Children under 6 months: Ask a doctor.
• 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 10 a.m.-2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information

• Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
• Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water, Isononyl Isononanoate, Cyclopentasiloxane, Isohexadecane, Glyceryl Stearate, PEG 100 Stearate, Glycerin, Silica, Potassium Cetyl Phosphate, Sorbitol, Sorbitan Stearate, Magnesium Aluminum Silicate, Xanthan Gum, Sodium Phytate, Xylitol, Nicotinamide, Butyrospermum Parkii (Shea ) Butter, Tocopheryl Acetate, Ascorbyl Tetraisopalmitate, Ectoin, Phenoxyethanol, Anhydroxylitol, Stearic Acid, Alumina, PPG-3 Benzyl Ether Myristate, PVP, Xylitylglucoside, Citrus Aurantium Bergamia fruit oil, Fragrance, Sodium Polyacrylate, Ethylhexyl Cocoate, Caprylyl Glycol, Alcohol.

SPL UNCLASSIFIED SECTION

Developed + Dist by NOON Aesthetics
TLV, 62153

PRINCIPAL DISPLAY PANEL - Kit Carton

AESTHETICS

Post-Procedure Treatment Program

MicroSoft Cleanser 15 mL / 0.5 Fl. Oz.
Smart Occlusion System 15 mL / 0.5 Fl. Oz.
Halo-Ronic Serum 15 mL / 0.5 Fl. Oz.

Optimal Moisturizing Guardian 15 mL / 0.5 Fl. Oz.
DeFlame 15 mL / 0.5 Fl. Oz.
Multi-Vit Sun Protector SPF 30 15 mL / 0.5 Fl. Oz.

INGREDIENTS AND APPEARANCE

NOON POST PROCEDURE PROGRAM 
allantoin, titanium dioxide, octocrylene, and avobenzone kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78863-2600

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78863-2600-1	1 in 1 CARTON	10/01/2023

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	15 mL
Part 2	1 BOTTLE	15 mL
Part 3	1 BOTTLE	15 mL
Part 4	1 BOTTLE	15 mL
Part 5	1 BOTTLE	15 mL
Part 6	1 BOTTLE	15 mL

Part 1 of 6

MICRO SOFT CLEANSER 
cleansing (cold creams, cleansing lotions, liquids, and pads) cream

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	PEG-20 GLYCERYL TRIISOSTEARATE (UNII: 4714JOJ107)
INGR	CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
INGR	ISOHEXADECANE (UNII: 918X1OUF1E)
INGR	PROPANEDIOL (UNII: 5965N8W85T)
INGR	WATER (UNII: 059QF0KO0R)
INGR	MACADAMIA OIL (UNII: 515610SU8C)
INGR	SQUALANE (UNII: GW89575KF9)
INGR	ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	STRONTIUM CHLORIDE HEXAHYDRATE (UNII: O09USB7Z44)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
INGR	NYMPHAEA ALBA ROOT (UNII: 866B05KWBR)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	BENZYL ALCOHOL (UNII: LKG8494WBH)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	ETHYLHEXYL COCOATE (UNII: I1MPW273QS)
INGR	PHYTATE SODIUM (UNII: 88496G1ERL)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		10/01/2023

Part 2 of 6

SMART OCCLUSION SYSTEM 
face and neck (excluding shaving preparations) cream

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	PROPANEDIOL (UNII: 5965N8W85T)
INGR	CHOLESTEROL (UNII: 97C5T2UQ7J)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	MINERAL OIL (UNII: T5L8T28FGP)
INGR	POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
INGR	CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
INGR	TURMERIC (UNII: 856YO1Z64F)
INGR	ISOSORBIDE DICAPRYLATE (UNII: 0IK29C4889)
INGR	OLEIC ACID (UNII: 2UMI9U37CP)
INGR	PALMITIC ACID (UNII: 2V16EO95H1)
INGR	BORON NITRIDE (UNII: 2U4T60A6YD)
INGR	CERAMIDE NP (UNII: 4370DF050B)
INGR	MAGNESIUM STEARATE (UNII: 70097M6I30)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	FERULIC ACID (UNII: AVM951ZWST)
INGR	CERAMIDE AP (UNII: F1X8L2B00J)
INGR	CERAMIDE NG (UNII: C04977SRJ5)
INGR	GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	1,2-HEXANEDIOL (UNII: TR046Y3K1G)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	EDETATE TRISODIUM (UNII: 420IP921MB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		10/01/2023

Part 3 of 6

HALO-RONIC SERUM 
face and neck (excluding shaving preparations) cream

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	PROPANEDIOL (UNII: 5965N8W85T)
INGR	TURMERIC (UNII: 856YO1Z64F)
INGR	AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
INGR	GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
INGR	HISTIDINE (UNII: 4QD397987E)
INGR	BETAINE (UNII: 3SCV180C9W)
INGR	SERINE (UNII: 452VLY9402)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	ARGININE (UNII: 94ZLA3W45F)
INGR	ALANINE (UNII: OF5P57N2ZX)
INGR	GLYCINE (UNII: TE7660XO1C)
INGR	LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)
INGR	THREONINE (UNII: 2ZD004190S)
INGR	PROLINE (UNII: 9DLQ4CIU6V)
INGR	GLUTAMIC ACID (UNII: 3KX376GY7L)
INGR	CALCIUM LACTATE ANHYDROUS (UNII: 2URQ2N32W3)
INGR	SODIUM LACTATE (UNII: TU7HW0W0QT)
INGR	CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	1,2-HEXANEDIOL (UNII: TR046Y3K1G)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		10/01/2023

Part 4 of 6

OPTIMAL MOISTURIZING GUARDIAN 
moisturizing cream

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	PROPANEDIOL (UNII: 5965N8W85T)
INGR	CHOLESTEROL (UNII: 97C5T2UQ7J)
INGR	SQUALANE (UNII: GW89575KF9)
INGR	POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
INGR	CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
INGR	TURMERIC (UNII: 856YO1Z64F)
INGR	ISOSORBIDE DICAPRYLATE (UNII: 0IK29C4889)
INGR	OLEIC ACID (UNII: 2UMI9U37CP)
INGR	PALMITIC ACID (UNII: 2V16EO95H1)
INGR	BORON NITRIDE (UNII: 2U4T60A6YD)
INGR	CERAMIDE NP (UNII: 4370DF050B)
INGR	MAGNESIUM STEARATE (UNII: 70097M6I30)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	BUCKMINSTERFULLERENE (UNII: NP9U26B839)
INGR	FERULIC ACID (UNII: AVM951ZWST)
INGR	CERAMIDE AP (UNII: F1X8L2B00J)
INGR	CERAMIDE NG (UNII: C04977SRJ5)
INGR	GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
INGR	BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	1,2-HEXANEDIOL (UNII: TR046Y3K1G)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	EDETATE TRISODIUM (UNII: 420IP921MB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		10/01/2023

Part 5 of 6

DEFLAME 
allantoin cream

Product Information
Item Code (Source)	NDC: 78863-1270
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z)	ALLANTOIN	5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
STRONTIUM CHLORIDE HEXAHYDRATE (UNII: O09USB7Z44)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
LAURETH-4 (UNII: 6HQ855798J)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
OCTYLDODECYL XYLOSIDE (UNII: 8Z6VNR46QM)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ACEGLUTAMIDE (UNII: 01J18G9G97)
OCTYLDODECANOL (UNII: 461N1O614Y)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
SORBITAN TRISTEARATE (UNII: 6LUM696811)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78863-1270-2	15 mL in 1 BOTTLE; 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	10/01/2023

Part 6 of 6

MULTI-VIT SUN PROTECTOR SPF 30 
titanium dioxide, octocrylene, and avobenzone cream

Product Information
Item Code (Source)	NDC: 78863-1230
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	90 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	48 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	14.4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISOHEXADECANE (UNII: 918X1OUF1E)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SORBITOL (UNII: 506T60A25R)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
XANTHAN GUM (UNII: TTV12P4NEE)
PHYTATE SODIUM (UNII: 88496G1ERL)
XYLITOL (UNII: VCQ006KQ1E)
NIACINAMIDE (UNII: 25X51I8RD4)
SHEA BUTTER (UNII: K49155WL9Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
ECTOINE (UNII: 7GXZ3858RY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ANHYDROXYLITOL (UNII: 8XWR7NN42F)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM OXIDE (UNII: LMI26O6933)
PPG-3 BENZYL ETHER MYRISTATE (UNII: 8075L58MKO)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)
ETHYLHEXYL COCOATE (UNII: I1MPW273QS)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78863-1230-2	15 mL in 1 BOTTLE; 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	10/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M016	10/01/2023

Labeler - Noon Aesthetics M.R. Ltd (600185560)

Establishment
Name	Address	ID/FEI	Business Operations
Noon Aesthetics M.R. Ltd		600185560	MANUFACTURE(78863-2600)