Label: PROCEDURE ENHANCEMENT SYSTEM- zinc oxide kit

  • NDC Code(s): 70604-030-02, 70604-040-00
  • Packager: Alastin Skincare, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 24, 2024

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  • 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.

    Principal Display Panel - Kit Carton
  • INGREDIENTS AND APPEARANCE
    PROCEDURE ENHANCEMENT SYSTEM 
    zinc oxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70604-040
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70604-040-001 in 1 BAG09/17/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PUMP 53.2 mL
    Part 21 BOTTLE, PUMP 29.6 mL
    Part 31 TUBE 29.6 mL
    Part 41 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 AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRCETEARYL METHICONE (15000 MW) (UNII: VY9RTR7MSY)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGRPOLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    INGRPOLYACRYLATE-13 (UNII: FS2D4T67EA)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRPOLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    INGRPOTASSIUM HYDROLYZED JOJOBA ESTERS (UNII: CH428W5O62)  
    INGRPANTHENOL (UNII: WV9CM0O67Z)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRSOY STEROL (UNII: PL360EPO9J)  
    INGRLINOLEIC ACID (UNII: 9KJL21T0QJ)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGRXANTHAN GUM (UNII: TTV12P4NEE)  
    INGRGLYCERYL MONOOLEATE (UNII: C4YAD5F5G6)  
    INGRSTEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
    INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRBETAINE (UNII: 3SCV180C9W)  
    INGRCAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRSORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    INGRBENZYL ALCOHOL (UNII: LKG8494WBH)  
    INGRTREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)  
    INGRANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    INGR.GAMMA.-TOCOPHEROL (UNII: 8EF1Z1238F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    153.2 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic09/17/2021
    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 AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    INGRDIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    INGRPENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
    INGRHEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
    INGRSOYBEAN OIL (UNII: 241ATL177A)  
    INGRPANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B)  
    INGRSQUALANE (UNII: GW89575KF9)  
    INGRCAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    INGRNARINGENIN (UNII: HN5425SBF2)  
    INGROLIVE OIL (UNII: 6UYK2W1W1E)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGRPROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    INGRSTEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    INGRARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    INGRDUNALIELLA SALINA (UNII: F4O1DKI9A6)  
    INGR.GAMMA.-TOCOPHEROL (UNII: 8EF1Z1238F)  
    INGRPALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)  
    INGRPALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    INGRASCORBYL PALMITATE (UNII: QN83US2B0N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    129.6 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic01/02/2017
    Part 3 of 4
    ULTRA LIGHT 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)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGRPOLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    INGRPOLYACRYLATE-13 (UNII: FS2D4T67EA)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRSQUALANE (UNII: GW89575KF9)  
    INGRPOLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    INGRPOTASSIUM HYDROLYZED JOJOBA ESTERS (UNII: CH428W5O62)  
    INGRPANTHENOL (UNII: WV9CM0O67Z)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRXANTHAN GUM (UNII: TTV12P4NEE)  
    INGRGLYCERYL MONOOLEATE (UNII: C4YAD5F5G6)  
    INGRSTEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)  
    INGRCERAMIDE NP (UNII: 4370DF050B)  
    INGRGREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    INGREDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    INGR.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
    INGRBETAINE (UNII: 3SCV180C9W)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRCAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    INGRPOLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRSORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    INGRSUCROSE STEARATE (UNII: 274KW0O50M)  
    INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
    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
    Cosmetic09/17/2021
    Part 4 of 4
    SILKSHIELD ALL MINERAL SUNSCREEN WITH TRIHEX TECHNOLOGY 
    zinc oxide cream
    Product Information
    Item Code (Source)NDC:70604-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.1995 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70604-030-0253.8 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02009/17/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02009/17/2021
    Labeler - Alastin Skincare, Inc. (085997348)
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