Label: DAILY BEAUTY REGIMEN WITH TRIHEX TECHNOLOGY- titanium dioxide and zinc oxide kit

  • NDC Code(s): 70604-011-00, 70604-050-00
  • Packager: Alastin Skincare, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Titanium Dioxide 8.9%Sunscreen
    Zinc Oxide 3.4%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 2 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

    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

    • 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

    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
  • INGREDIENTS AND APPEARANCE
    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)