Label: SPF ELIO DROPS 30 GLOW- zinc oxide cream

  • NDC Code(s): 62742-4233-1, 62742-4233-2
  • Packager: Allure Labs Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 28, 2023

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

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS...………... ZINC OXIDE 15.6%

  • 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

    DISCONTINUE USE IF IRRITATION OR REDNESS OCCURS.

  • WHEN USING

    WHEN USING THIS PRODUCT KEEP OUT OF EYES. IF CONTACT OCCURS, RINSE WITH WATER.

  • STOP USE

    STOP USE AND ASK A DOCTOR IF SEVERE IRRITATION OCCURS.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF THE REACH OF CHILDREN IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS FOR SUNSCREEN USE: APPLY GENEROUSLY 15 MINUTES BEFORE SUN EXPOSURE. APPLY TO ALL SKIN EXPOSED BY THE SUN. 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 SUN, ESPECIALLY FROM 10 A.M. - 2 P.M. WEAR LONG-SLEEVED SHIRTS, PANTS, HATS AND SUNGLASSES. REAPPLY AT LEAST EVERY 2 HOURS. USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING IMMEDIATELY AFTER TOWEL DRYING 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:ISODODECANE, SQUALANE, POLYSILICONE-11, PROPANEDIOL DICAPRYLATE/CAPRATE, CAPRYLIC/CAPRIC, TRIGLYCERIDE, POLYHYDROXYSTEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, TRIETHOXYCAPRYLY, SILANE, LECITHIN, HYDROGENATED PALM OIL, HYDROGENATED RAPESEED OIL, COCO-CAPRYLATE, CAPRATE, HYDRATED SILICA, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, TOCOPHERYL ACETATE, TETRAHEXYLDECYL ASCORBATE, CAMELLIA OLEIFERA SEED OIL, POLYGLYCERYL-6 POLYRICINOLEATE, DILINOLEIC ACID/BUTANEDIOL COPOLYMER, DISODIUM STEAROYL GLUTAMATE, PRUNUS ARMENIACA, KERNEL OIL, CASTOR OIL/IPDI COPOLYMER, ALOE BARBADENESIS LEAF EXTRACT, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, PISTACIA LENTISCUS (MASTIC) GUM OIL, ARGANIA SPINOSA KERNEL OIL, BISABOLOL, MAY CONTAIN +/- IRON OXIDES (CI 77492, CI 77491, CI 77499

  • PRINCIPAL DISPLAY PANEL

    SPFEliodrops30Glow

  • INGREDIENTS AND APPEARANCE
    SPF ELIO DROPS 30 GLOW 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4233
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15.6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU)  
    DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SQUALANE (UNII: GW89575KF9)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    HYDROGENATED PALM OIL (UNII: 257THB963H)  
    SILANE (UNII: 5J076063R1)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    DILINOLEIC ACID/BUTANEDIOL COPOLYMER (UNII: 1F2S8T535O)  
    ISODODECANE (UNII: A8289P68Y2)  
    CAMELLIA OIL (UNII: T1PE06G0VE)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    PISTACIA LENTISCUS RESIN OIL (UNII: ZJ39788YVA)  
    PROPANEDIOL DICAPRYLATE/CAPRATE (UNII: F53961BX4F)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    RED BREAST CICHLID (UNII: 492WK4ZA3B)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GINGER (UNII: C5529G5JPQ)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4233-21 in 1 CARTON10/28/2023
    1NDC:62742-4233-129.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/28/2023
    Labeler - Allure Labs Inc (926831603)
    Registrant - Allure Labs Inc (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs Inc926831603manufacture(62742-4233)