Label: DAILY SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 20, 2024

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

  • Drug Facts

  • Active ingredient

    Zinc oxide 15.5%

    Purpose

    Sunscreen

  • 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

    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 use and ask a doctor if

    • rash occurs

    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
    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating
    • 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 the sun, especially from 10 a.m.-2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses
  • Other information

    • Protect the product in this container from excessive heat and direct sun
  • Inactive ingredients

    Water (Aqua), C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Dimethicone, Glycerin, Ethylhexyl Palmitate, Propanediol, Shea Butter (Butyrospermum Parkii), Safflower (Carthamus Tinctorius) Oleosomes, Glyceryl Stearate Se, Polyhydroxystearic Acid, Sorbitan Isostearate, Cetyl Alcohol, Pentaerythrityl Tetraisostearate, Phenyl Trimethicone, Silica, Inulin Lauryl Carbamate, Ethylhexylglycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Hydroxyacetophenone, Polysilicone-11, Xanthan Gum, Gluconolactone, Trisodium Ethylenediamine Disuccinate, Sodium Citrate, Sodium Benzoate, Tocopherol, Citric Acid.

  • Package Labeling:

    LabelInner Package

  • INGREDIENTS AND APPEARANCE
    DAILY SUNSCREEN BROAD SPECTRUM SPF 30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:31720-231
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION155 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    INULIN LAURYL CARBAMATE (UNII: 48RFF58ESG)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:31720-231-101 in 1 BOX11/15/2023
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/15/2023
    Labeler - S+ (572406531)