YOUTH PROTECTION SPF 30 (ZINC OXIDE AND TITANIUM DIOXIDE) CREAM [ALLURE LABS, INC]

YOUTH PROTECTION SPF 30 (ZINC OXIDE AND TITANIUM DIOXIDE) CREAM [ALLURE LABS, INC]
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NDC 62742-4068-1, 62742-4068-2, 62742-4068-3, 62742-4068-4
Set ID d7c8e1b5-106c-4fac-8069-796cd27e629d
Category HUMAN OTC DRUG LABEL
Packager Allure Labs, Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredients:

    Zinc Oxide: 18.6%

    Titanium Dioxide: 2.0%

  • PURPOSE

    Purpose:Sunscreen

  • INDICATIONS & USAGE

    Uses:

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

    Warings:

    • For External Use Only
    • Do not use on damged or broken skin
  • WHEN USING

    When using this product keep out of eyes. 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 helps or contact a Poison Control Center right away

  • INDICATIONS & USAGE

    Directions:

    • Apply liberally 15 minutes before sun exposure.
    • Children under 6 month of age: Ask a doctor.
    • Reapply at least every 2 hours.
  • OTHER SAFETY INFORMATION

    Other information:

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

    Inactive Ingredients: Water (Aqua), Cyclopentasiloxane, Glycerin, Butyrospermum Parkii Nut Extract, Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Jojoba Esters , Glyceryl Stearate, PEG-100 Stearate, Sorbitan Stearate, PEG-100, Tetrahexyldecyl Ascorbate, Cyclohexasiloxane, Galactoarabinan, Cetyl Alcohol, Bis(Cyano Butylacetate) Anthracenediylidene, Glyceryl Acrylate/Acrylic Acid Copolymer , Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Adipic Acid/Neopentyl Glycol Crosspolymer, VP/VA Copolymer, Hydroxypropyl Methylcellulose, Amodimethicone, Steareth-20, Caprylic/Capric Triglyceride, Teprenone, Acetyl Hexapeptide-30, Arginine, Sodium Hyaluronate , Hydrolyzed Glycosaminoglycans , Propylene Glycol, Polygonum Aviculare Extract, Cetearyl Olivate, Sorbitan Olivate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Squalane, Polysorbate 60, Xanthan Gum, Camellia Sinensis Leaf Extract, Acetyl Hexapeptide-8, Gardenia Jasminoides Meristem Cell Culture, Sclerotium Gum, C12-15 Alkyl Benzoate, Tribehenin, Ceramide NG, PEG-10 Phytosterol, Palmitoyl Hexapeptide-12, Tocopheryl Acetate, Tocopherol, Lecithin , Arabidopsis Thaliana Extract , Micrococcus Lysate, Plankton Extract , Glucosamine HCl , Laminaria Digitata Extract, Saccharomyces Cerevisiae Extract, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Urea, PPG-12/SMDI Copolymer, Leontopodium Alpinum Meristem Cell Culture, Crithmum Maritimum Extract, Ergothioneine, Aluminum Hydroxide, Stearic Acid, Chlorphenesin, Sodium Benzoate, Potassium Sorbate

  • PRINCIPAL DISPLAY PANEL

    Manufactured for DermaQuest®, Inc.

    Hayward, CA 94544

    1272 GK,NL Made in USA

    dermaquestinc.com

    IMGDQIYPSPF3020

  • INGREDIENTS AND APPEARANCE
    YOUTH PROTECTION SPF 30 
    zinc oxide and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4068
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION186 mg  in 1 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)  
    CRITHMUM MARITIMUM (UNII: J7IHY79BKY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SHEANUT OIL (UNII: O88E196QRF)  
    JOJOBA BUTTER (UNII: XIA46H803R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    POLYETHYLENE GLYCOL 4500 (UNII: TVH7653921)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    GALACTOARABINAN (UNII: SL4SX1O487)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TEPRENONE (UNII: S8S8451A4O)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    SQUALANE (UNII: GW89575KF9)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    CERAMIDE 2 (UNII: C04977SRJ5)  
    PEG-10 RAPESEED STEROL (UNII: 258O76T85M)  
    PALMITOYL OLIGOPEPTIDE (UNII: HO4ZT5S86C)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    YEAST (UNII: 3NY3SM6B8U)  
    UREA (UNII: 8W8T17847W)  
    PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    BUTYL CYANOACETATE (UNII: F9H6L20VOH)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    ARGININE (UNII: 94ZLA3W45F)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
    HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)  
    LEONTOPODIUM ALPINUM (UNII: 7R4LQP52DM)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
    AMODIMETHICONE (240 CST) (UNII: VA5T401RWV)  
    GARDENIA JASMINOIDES WHOLE (UNII: 0PK353KHF0)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4068-21 in 1 CARTON10/15/2019
    1NDC:62742-4068-156.7 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:62742-4068-328.3 g in 1 TUBE; Type 0: Not a Combination Product10/15/2019
    3NDC:62742-4068-4113 g in 1 TUBE; Type 0: Not a Combination Product10/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/15/2015
    Labeler - Allure Labs, Inc (926831603)
    Registrant - Allure Labs, Inc (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs, Inc926831603manufacture(62742-4068)

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