Label: QUENCH AND PROTECT HYDRATING SPF30- zinc dioxide and titanium dioxide cream

  • NDC Code(s): 62742-4230-1, 62742-4230-2
  • Packager: Allure Labs.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 23, 2023

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

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:
    Zinc Oxide - 6.0%
    Titanium Dioxide 4.7%

  • PURPOSE

    Purpose: Sunscreen

  • INDICATIONS & USAGE

    Uses: Helps prevent sunburn. If used as directed with other sun protection measures, this product decreases the risk of skin cancer and early skin aging caused by the sun.

  • WARNINGS

    Warning:

    For external use only

  • DO NOT USE

    Do not use on damage or broken skin.

  • WHEN USING

    When using this product keep out of eye. Rinse with water to remove.

  • STOP USE

    Stop use and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children if product is swallowed, get medical help or contact a poison control center right away.

  • DOSAGE & ADMINISTRATION

    Direction:

    Apply liberally 15 minutes before sun exposure.

    Children under 6 month of age: Ask a doctor

    Reapply at least every 2 hours.

    Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decreases 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 10 am – 2.0 pm, Wear long – sleeved shirts, pants, hats and sunglasses.

  • OTHER SAFETY INFORMATION

    Other Information:

    Protect the product in this container from excessive heat and direct sun.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENT: Water, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Dimethicone, Cyclohexasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Aluminum Hydroxide, Stearic Acid, Glycerin, Cetearyl Olivate,Hexyl Laurate, Sodium Chloride, Pichia/ Resveratrol, Ferment Extract, Sorbitane Olivate, Dimethicone/Polyglycerin -3 Crosspolymer, Polyglyceryl-4 Isostearate, Panthenol, Cetyl PEG/PPG-10/1 Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl HexylDimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Venyl Dimethicone, Crosspolymer, Sodium Hyaluronate, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Fragrance, Tocopheryl Acetate.

  • PRINCIPAL DISPLAY PANEL

    Quench and Protect Hydrating SPF 30

  • INGREDIENTS AND APPEARANCE
    QUENCH AND PROTECT HYDRATING SPF30 
    zinc dioxide and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4230
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    WATER (UNII: 059QF0KO0R)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    PRUNUS PERSICA SEED (UNII: V9C81470RR)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    RESVERATROL (UNII: Q369O8926L)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)  
    TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    CYCLOMETHICONE 7 (UNII: KCK5L8VU47)  
    DIMETHICONE/POLYGLYCERIN-3 CROSSPOLYMER (UNII: 2P2G24V6T9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4230-21 in 1 CARTON08/23/2023
    1NDC:62742-4230-157 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02008/23/2023
    Labeler - Allure Labs. (926831603)
    Registrant - Allure Labs (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs926831603manufacture(62742-4230)