Label: DAILY PREVENTION ULTRA DEFENSE MOISTURIZER SPF 50- homosalate, octisalate,octocrylene and zinc oxide cream

  • NDC Code(s): 62742-4255-1, 62742-4255-2, 62742-4255-3, 62742-4255-4
  • Packager: Allure Labs
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 19, 2024

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

  • ACTIVE INGREDIENT

    Active ingredients

    Homosalate 7.3%

    Octisalate 5.0%

    Octocrylene 9.9%

    Zinc Oxide 7.0%

  • PURPOSE

    Purpose; Sunscreen

  • INDICATIONS & USAGE

    Uses • helps prevent sunburn • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  • WARNINGS

    Warnings • For external use only

  • DO NOT USE

    Do not use • on damaged 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 swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions • apply generously 15 minutes before sun exposure • children under 6 months of age: Ask a doctor • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • 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 10 a.m.-2 p.m. • 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 • Due to the presence of botanical ingredients, this product may change in color over time.

  • INACTIVE INGREDIENT

    Inactive ingredients : Aqua/Water/Eau, Cetyl PEG/PPG-10/1 Dimethicone, Hydrogenated Ethylhexyl Olivete, C12-15 Alkyl Benzoate, C13-15 Alkane, Theobroma Cacao Seed Butter, Hydrogenated Castor Oil, Aloe Barbadensis Leaf Juice, Ethylhexyl Stearate, Isoamyl Laurate, Glycerin, Ethylhexyl Palmitate, Phenoxyethanol, Euphorbia Cerifera Wax, Polyhydroxystearic Acid, Sodium Chloride, Acetyl Zingerone, Caprylic/Capric Triglyceride, Hydrogenated Olive Oil Unsaponifiables, Tocopheryl Acetate, Ethylhexylglycerin, Hydrated Silica, Phosphatidylcholine, Mannitol, Vanilla Planifolia Fruit Extract, Methyl Propanediol, Benzoic Acid, Ectoin, Palmitic Acid, Caprylyl Glycol, Stearic Acid, Haematococcus Pluvialis Extract, Tetrahexyldecyl Ascorbate, Panthenol, Phenylpropanol, Pentaerythrityl Tetra-Di-T-Butyl Hydroxydrocinnamate.

  • PRINCIPAL DISPLAY PANEL

    Daily Prevention Ultra Defense Moisturizer SPF 50

  • INGREDIENTS AND APPEARANCE
    DAILY PREVENTION ULTRA DEFENSE MOISTURIZER SPF 50 
    homosalate, octisalate,octocrylene and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4255
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9.9 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)  
    C13-15 ALKANE (UNII: 114P5I43UJ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ECTOINE (UNII: 7GXZ3858RY)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    VANILLA (UNII: Q74T35078H)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    PHOSPHATIDYLCHOLINE TRANSLOCATOR ABCB4 (UNII: 9EI49ZU76O)  
    MANNITOL (UNII: 3OWL53L36A)  
    WATER (UNII: 059QF0KO0R)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    ACETYL ZINGERONE (UNII: V9D92S9YE5)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    HYDROGENATED OLIVE OIL UNSAPONIFIABLES (UNII: B8MIX97W95)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HYDROGENATED ETHYLHEXYL OLIVATE (UNII: JBH5K4WD8L)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4255-17 g in 1 TUBE; Type 0: Not a Combination Product03/19/2024
    2NDC:62742-4255-31 in 1 CARTON03/19/2024
    2NDC:62742-4255-273 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:62742-4255-4142 g in 1 TUBE; Type 0: Not a Combination Product03/19/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/19/2024
    Labeler - Allure Labs (926831603)
    Registrant - Allure Labs (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs926831603manufacture(62742-4255)