Label: HALE AND HUSH BROAD SPECTRUM SPF 30 SPF 30- zinc oxide cream

  • NDC Code(s): 83677-610-58
  • Packager: Eclectic Solutions LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2023

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

  • ACTIVE INGREDIENT

    Zinc Oxide 13.50%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    * Help 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 th

  • 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.

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

  • Directions

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • 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 decrease this risk, regularly use a sunscreen with broad spectrum spf of 15 or higher and other sun protection measure including:
    • limit time in the sun, especially from 10am to 2 pm
    • wear long-sleeve shirts, pants, hats and sunglasses
    • children under 6 months: Ask a doctor
  • INACTIVE INGREDIENT

    Inactive Ingredients: Aqua (Water), Caprylic/Capric Triglyceride, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Glycerin, Isodecyl Neopentanoate, Ethyl Macadamiate, Aleurites Moluccanus Seed Oil, Hydroxypropyl Starch Phosphate, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Water, Ergothioneine [(L), Hordeum Distichon (Barley) Extract, Macadamia Ternifolia Seed Oil, Porphyra Umbilicalis (Red Algae) Extract, Santalum Album (Sandalwood) Extract, Phellodendron Amurense Bark Extract, Bisabolol (L-alpha), Glyceryl Isostearate, Sodium Stearoyl Lactylate, Polyglycery1-10 Pentastearate, Polyhydroxystearic Acid, Tocopheryl Acetate (D-alpha), Tocopherol (D-alpha), Lecithin, Malic Acid (L), Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Alcohol, Cetearyl Alcohol, Behenyl Alcohol, Hydroxypropyl Methylcellulose, Sodium Lactate, Phytic Acid, Citric Acid, Sodium Hydroxide

  • OTHER SAFETY INFORMATION

    Protect this product from excessive heat and direct sun

  • QUESTIONS

    602-858-5814

    haleandhush.com

    Distributed by Eclectic Solutions LLC

    4820 South Ash Ave #102

    Tempe AZ 85282

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    HALE AND HUSH BROAD SPECTRUM SPF 30  SPF 30
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83677-610
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE13.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
    POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MALIC ACID, L- (UNII: J3TZF807X5)  
    PEG-60 GLYCERYL STEARATE (UNII: 85O35YN6YY)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    ALEURITES MOLUCCANA SEED (UNII: J87WJ3E7VW)  
    PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    ERGOTHIONEINE (UNII: BDZ3DQM98W)  
    SANDALWOOD (UNII: 3641YW25N2)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    BARLEY (UNII: 5PWM7YLI7R)  
    ALCOHOL (UNII: 3K9958V90M)  
    LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    HYDROXYPROPYL CORN STARCH (5% SUBSTITUTION BY WEIGHT) (UNII: 9M44R3409A)  
    ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    FYTIC ACID (UNII: 7IGF0S7R8I)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83677-610-5855 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/02/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/02/2018
    Labeler - Eclectic Solutions LLC (068556928)