PROCEDURE ENHANCEMENT SYSTEM- zinc oxide kit

Procedure Enhancement System by

Drug Labeling and Warnings

Procedure Enhancement System by is a Otc medication manufactured, distributed, or labeled by Alastin Skincare, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Zinc Oxide 19.95%

Purpose

Sunscreen

Uses

• Helps prevent sunburn

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 a doctor if rash occurs.

• 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
• Reapply:
  • After 40 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every two hours
• Children under 6 months of age:
  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 10am - 2pm
• Wear long-sleeved shirts, pants, hats and sunglasses

Inactive Ingredients

Dimethicone, Cyclopentasiloxane, Polysilicone-11, Squalane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, HDI/Trimethylol Hexyllactone Crosspolymer, Methyl Methacrylate Crosspolymer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Palmitoyl Hexapeptide-12, Palmitoyl Tripeptide-1, Dunaliella Salina Extract, Ectoin, Hydroxymethoxyphenyl Decanone, Tocopherol, Caprylic/Capric Triglyceride, Stearalkonium Hectorite, Disteardimonium Hectorite, Pentaerythrityl Tetraisostearate, Propylene Carbonate

Other Information

• Protect the product in this container from excessive heat and direct sun.
  Store at room temperature 15° - 30°C (59° - 86°F).

SPL UNCLASSIFIED SECTION

Distributed by Alastin Skincare®, Inc., a Galderma Company
Carlsbad, CA 92010

PRINCIPAL DISPLAY PANEL - Kit Carton

074A

ALASTIN®
SKINCARE

PROCEDURE
ENHANCEMENT
SYSTEM

with TriHex Technology®

Expertly formulated to complement in-office cosmetic treatments by enhancing
results and accelerating recovery. Ideal for sensitive and post-procedure skin.

INGREDIENTS AND APPEARANCE

PROCEDURE ENHANCEMENT SYSTEM 
zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70604-040

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70604-040-00	1 in 1 BAG	09/17/2021

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PUMP	53.2 mL
Part 2	1 BOTTLE, PUMP	29.6 mL
Part 3	1 TUBE	29.6 mL
Part 4	1 TUBE	53.8 g

Part 1 of 4

ULTRA CALM CLEANSING 
cleansing (cold creams, cleansing lotions, liquids, and pads) [skin care preparations (creams, lotions, powder, and sprays)] 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	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	CETEARYL METHICONE (15000 MW) (UNII: VY9RTR7MSY)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
INGR	POLYACRYLATE-13 (UNII: FS2D4T67EA)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
INGR	POTASSIUM HYDROLYZED JOJOBA ESTERS (UNII: CH428W5O62)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	SOY STEROL (UNII: PL360EPO9J)
INGR	LINOLEIC ACID (UNII: 9KJL21T0QJ)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	GLYCERYL MONOOLEATE (UNII: C4YAD5F5G6)
INGR	STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	BETAINE (UNII: 3SCV180C9W)
INGR	CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	BENZYL ALCOHOL (UNII: LKG8494WBH)
INGR	TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)
INGR	ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
INGR	.GAMMA.-TOCOPHEROL (UNII: 8EF1Z1238F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		53.2 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		09/17/2021

Part 2 of 4

REGENERATING SKIN NECTAR 
face and neck (excluding shaving preparations), leave-on [skin care preparations (creams, lotions, powder, and sprays)] lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
INGR	DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
INGR	PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
INGR	HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
INGR	SOYBEAN OIL (UNII: 241ATL177A)
INGR	PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B)
INGR	SQUALANE (UNII: GW89575KF9)
INGR	CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	NARINGENIN (UNII: HN5425SBF2)
INGR	OLIVE OIL (UNII: 6UYK2W1W1E)
INGR	LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
INGR	PROPYLENE CARBONATE (UNII: 8D08K3S51E)
INGR	STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
INGR	ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INGR	DUNALIELLA SALINA (UNII: F4O1DKI9A6)
INGR	.GAMMA.-TOCOPHEROL (UNII: 8EF1Z1238F)
INGR	PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
INGR	PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
INGR	ASCORBYL PALMITATE (UNII: QN83US2B0N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		29.6 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		01/02/2017

Part 3 of 4

ULTRA LIGHT MOISTURIZER 
moisturizing [skin care preparations (creams, lotions, powder, and sprays)] lotion

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
INGR	POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
INGR	POLYACRYLATE-13 (UNII: FS2D4T67EA)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	SQUALANE (UNII: GW89575KF9)
INGR	POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
INGR	POTASSIUM HYDROLYZED JOJOBA ESTERS (UNII: CH428W5O62)
INGR	PANTHENOL (UNII: WV9CM0O67Z)
INGR	CAPRYLYL GLYCOL (UNII: 00YIU5438U)
INGR	XANTHAN GUM (UNII: TTV12P4NEE)
INGR	GLYCERYL MONOOLEATE (UNII: C4YAD5F5G6)
INGR	STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
INGR	CERAMIDE NP (UNII: 4370DF050B)
INGR	GREEN TEA LEAF (UNII: W2ZU1RY8B0)
INGR	EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
INGR	.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
INGR	BETAINE (UNII: 3SCV180C9W)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
INGR	POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
INGR	SUCROSE STEARATE (UNII: 274KW0O50M)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		29.6 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
Cosmetic		09/17/2021

Part 4 of 4

SILKSHIELD ALL MINERAL SUNSCREEN WITH TRIHEX TECHNOLOGY 
zinc oxide cream

Product Information
Item Code (Source)	NDC: 70604-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.1995 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
SQUALANE (UNII: GW89575KF9)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
DUNALIELLA SALINA (UNII: F4O1DKI9A6)
ECTOINE (UNII: 7GXZ3858RY)
1-(4-HYDROXY-3-METHOXYPHENYL)-DECAN-3-ONE (UNII: BO24ID7E9U)
TOCOPHEROL (UNII: R0ZB2556P8)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70604-030-02	53.8 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	09/17/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	09/17/2021

Labeler - Alastin Skincare, Inc. (085997348)