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).

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.

PROCEDURE ENHANCEMENT SYSTEM
zinc oxide kit

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

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

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
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

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
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)

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70604-030-02	53.8 g in 1 TUBE; Type 0: Not a Combination Product

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

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

Labeler - Alastin Skincare, Inc. (085997348)

Procedure Enhancement System