Label: ELROEL PANG PANG SUN CUSHION PLUS- zinc oxide, titanium dioxide, octinoxate, octisalate cream

  • NDC Code(s): 83154-004-01, 83154-004-02
  • Packager: MONOGLOT HOLDINGS Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 2, 2024

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

  • ACTIVE INGREDIENT

    ZINC OXIDE 9.70%

    OCTINOXATE 7.00%
    OCTISALATE 3.00%

    TITANIUM DIOXIDE 1.52%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    Helps prevent sunburn

  • DOSAGE & ADMINISTRATION

    For sunscreen use:
    ■ apply liberally 15 minutes before sun exposure
    ■ reapply at least every two hours
    ■ use a water resistant sunscreen if swimming or sweating
    ■ 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
    ■ children under 6 months of age: ask a doctor

  • 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 using and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

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

  • INACTIVE INGREDIENT

    Aloe Barbadensis Leaf JuiceCyclopentasiloxane, Butylene Glycol, Butyloctyl Salicylate, Caprylyl Methicone, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Niacinamide, Diphenylsiloxy Phenyl Trimethicone, Alcohol Denat., Propylene Glycol Dicaprylate, Sodium Chloride, Silica, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Hydroxyacetophenone, Synthetic Beeswax, Disteardimonium Hectorite, Triethoxycaprylylsilane, Dipropylene Glycol, Water, Fragrance, Caprylyl Glycol, Squalane, Tocopheryl Acetate, Propylene Carbonate, Ethylhexylglycerin, Glycerin, Adenosine, Butyrospermum Parkii (Shea) Butter, Xylitylglucoside, Anhydroxylitol, Disodium EDTA, Methyl Diisopropyl Propionamide, Laminaria Japonica Extract, Ulmus Davidiana Root Extract, Aloe Barbadensis Leaf Extract, Viola Mandshurica Flower Extract, Dioscorea Japonica Root Extract, Xylitol, CI 77492, 1,2-Hexanediol, Glucose, Menthyl Lactate, Beeswax, Ethyl Menthane Carboxamide, Glyceryl Stearate, Caprylic/Capric Triglyceride, Hydrogenated Phosphatidylcholine, Calcium Pantothenate, Centella Asiatica Extract, Sucrose Stearate, Stearamidopropyl Dimethylamine Lactate, Phenethyl Alcohol, PEG-100 Stearate, Sodium Ascorbyl Phosphate, Dipotassium Glycyrrhizate, Cetearyl Alcohol, Polyquaternium-67, Pyridoxine HCl, Madecassoside, Madecassic Acid, Asiaticoside, Asiatic Acid

  • OTHER SAFETY INFORMATION

    Protect the product in this container from excessive heat and direct sunlight

  • PRINCIPAL DISPLAY PANEL

    Pang Pang Update

  • INGREDIENTS AND APPEARANCE
    ELROEL PANG PANG SUN CUSHION PLUS 
    zinc oxide, titanium dioxide, octinoxate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83154-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.52 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION9.7 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ADENOSINE (UNII: K72T3FS567)  
    XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)  
    ANHYDROXYLITOL (UNII: 8XWR7NN42F)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
    LAMINARIA JAPONICA (UNII: WE98HW412B)  
    ULMUS DAVIDIANA ROOT (UNII: URQ79U8261)  
    VIOLA MANDSHURICA FLOWER (UNII: 46MR945M6X)  
    DIOSCOREA JAPONICA TUBER (UNII: I43FCF3356)  
    XYLITOL (UNII: VCQ006KQ1E)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
    SUCROSE STEARATE (UNII: 274KW0O50M)  
    STEARAMIDOPROPYL DIMETHYLAMINE LACTATE (UNII: 31Q9363QSX)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    MADECASSOSIDE (UNII: CQ2F5O6YIY)  
    MADECASSIC ACID (UNII: M7O1N24J82)  
    ASIATICOSIDE (UNII: PKO39VY215)  
    ASIATIC ACID (UNII: 9PA5A687X5)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    AMILOXATE (UNII: 376KTP06K8)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL DICAPRYLATE (UNII: 581437HWX2)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    WATER (UNII: 059QF0KO0R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SQUALANE (UNII: GW89575KF9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83154-004-021 in 1 CARTON02/03/2024
    1NDC:83154-004-0115 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/03/2024
    Labeler - MONOGLOT HOLDINGS Inc. (694628175)
    Registrant - MONOGLOT HOLDINGS Inc. (694628175)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cit Co., Ltd.690081646manufacture(83154-004)