DAILY BEAUTY REGIMEN WITH TRIHEX TECHNOLOGY- titanium dioxide and zinc oxide 
Alastin Skincare, Inc.

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Daily Beauty Regimen with TriHex Technology®

Drug Facts

Active IngredientsPurpose
Titanium Dioxide 8.9%Sunscreen
Zinc Oxide 3.4%Sunscreen

Uses

Warnings

  • 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

Inactive Ingredients

Inactive Ingredients:

Water/Aqua/Eau, Cyclopentasiloxane, Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Butylene Glycol, Aluminum Hydroxide, Stearic Acid, Thermus Thermophillus Ferment, PEG-9 Polydimethylsiloxyethyl Dimethicone, Sodium Chloride, Camellia Sinensis Leaf Extract, Hydroxymethoxyphenyl Decanone, Dunaliella Salina Extract, Asteriscus Graveolens Flower/Fruit/Leaf/Stem Extract, Ergothioneine, Ectoin, Squalane, Glycerin, Caprylic/Capric Triglyceride, Tocopherol, Tocopheryl Acetate, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexylglycerin, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, PEG/PPG-18/18 Dimethicone, Triethoxycaprylylsilane, Sodium Citrate, Potassium Sorbate, Dipropylene Glycol, Phenoxyethanol, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499).

Other Information

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

PRINCIPAL DISPLAY PANEL - Kit Carton

ALASTIN®
SKINCARE

DAILY BEAUTY
REGIMEN

with TriHex Technology®

Designed to help restore and renew skin to
maintain a healthy, youthful appearance.

PRINCIPAL DISPLAY PANEL - Kit Carton
DAILY BEAUTY REGIMEN WITH TRIHEX TECHNOLOGY 
titanium dioxide and zinc oxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70604-050
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70604-050-001 in 1 CARTON09/24/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 12 g
Part 21 BOTTLE, PLASTIC 53.2 mL
Part 31 BOTTLE, PUMP 14.8 mL
Part 41 TUBE 29.6 mL
Part 1 of 4
HYDRATINT PRO MINERAL BROAD SPECTRUM SUNSCREEN SPF 
titanium dioxide and zinc oxide cream
Product Information
Item Code (Source)NDC:70604-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.089 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.034 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)  
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
1-(4-HYDROXY-3-METHOXYPHENYL)-DECAN-3-ONE (UNII: BO24ID7E9U)  
DUNALIELLA SALINA (UNII: F4O1DKI9A6)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
ECTOINE (UNII: 7GXZ3858RY)  
SQUALANE (UNII: GW89575KF9)  
GLYCERIN (UNII: PDC6A3C0OX)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorBROWNScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70604-011-0012 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM02009/24/2021
Part 2 of 4
GENTLE CLEANSER 
cleansing (cold creams, cleansing lotions, liquids, and pads) [skin care preparations (creams, lotions, powder, and sprays)] liquid
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRSODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
INGROAT (UNII: Z6J799EAJK)  
INGRODETIGLUCAN (UNII: Q6X9CNN54X)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRLEVOMENOL (UNII: 24WE03BX2T)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
INGRPANTOLACTONE (UNII: J288D7O0JS)  
INGR1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
INGRMAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
INGRLAVENDER OIL (UNII: ZBP1YXW0H8)  
INGRORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
INGRSTANNIC OXIDE (UNII: KM7N50LOS6)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRTITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
153.2 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic
Part 3 of 4
RESTORATIVE SKIN COMPLEX 
moisturizing [skin care preparations (creams, lotions, powder, and sprays)] lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRPROPANEDIOL (UNII: 5965N8W85T)  
INGRNIACINAMIDE (UNII: 25X51I8RD4)  
INGRISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
INGRPOLYACRYLATE-13 (UNII: FS2D4T67EA)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGRPALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)  
INGRPALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
INGRPALMITOYL TRIPEPTIDE-5 TRIFLATE (UNII: 4IV5XO4TGK)  
INGRPALMITOYLLYSYLVALYLDIAMINOBUTYROYLTHREONINE TRIFLUOROACETATE (UNII: CL9S2UKN56)  
INGRPALMITOYLLYSYLVALYLDIAMINOBUTYRIC ACID TRIFLUOROACETATE (UNII: 79390Q4BYV)  
INGRACETYL HEXAPEPTIDE-38 (UNII: XUJ27AR5LA)  
INGRASCORBYL PALMITATE (UNII: QN83US2B0N)  
INGRSWERTIA CHIRAYITA WHOLE (UNII: 98BFC3JT53)  
INGRPEA PROTEIN (UNII: 7Q50F46595)  
INGRORNITHINE (UNII: E524N2IXA3)  
INGRCERAMIDE NP (UNII: 4370DF050B)  
INGRERGOTHIONEINE (UNII: BDZ3DQM98W)  
INGRDUNALIELLA SALINA (UNII: F4O1DKI9A6)  
INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
INGRTREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)  
INGROLIVE OIL (UNII: 6UYK2W1W1E)  
INGRSOYBEAN OIL (UNII: 241ATL177A)  
INGRSHEA BUTTER (UNII: K49155WL9Y)  
INGRBETAINE (UNII: 3SCV180C9W)  
INGRSQUALANE (UNII: GW89575KF9)  
INGRCAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRCAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
INGRPOLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRLEVULINIC ACID (UNII: RYX5QG61EI)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRSUNFLOWER OIL (UNII: 3W1JG795YI)  
INGRP-ANISIC ACID (UNII: 4SB6Y7DMM3)  
INGRSORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
114.8 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic
Part 4 of 4
ULTRA NOURISHING MOISTURIZER 
moisturizing [skin care preparations (creams, lotions, powder, and sprays)] lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
INGRCAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRGLYCERYL MONOOLEATE CITRATE (UNII: NLE5KIG74K)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGRPALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
INGRPALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)  
INGRSUNFLOWER OIL (UNII: 3W1JG795YI)  
INGROAT (UNII: Z6J799EAJK)  
INGRTREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)  
INGRRICE BRAN (UNII: R60QEP13IC)  
INGRROSEMARY (UNII: IJ67X351P9)  
INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
INGRLEVOMENOL (UNII: 24WE03BX2T)  
INGR.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
INGRGLYCERYL MONOOLEATE (UNII: C4YAD5F5G6)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRSOY STEROL (UNII: PL360EPO9J)  
INGRLINOLEIC ACID (UNII: 9KJL21T0QJ)  
INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
INGRBETAINE (UNII: 3SCV180C9W)  
INGRPOLYACRYLATE-13 (UNII: FS2D4T67EA)  
INGRPOLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGRCAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRBENZYL ALCOHOL (UNII: LKG8494WBH)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRSORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
129.6 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM02009/24/2021
Labeler - Alastin Skincare, Inc. (085997348)

Revised: 12/2023
Document Id: 3414157e-6c31-4152-8042-3f53cb216c74
Set id: 4092c96d-ed3f-4ffd-b25f-19abfe46c73a
Version: 1
Effective Time: 20231220
 
Alastin Skincare, Inc.