Label: SPF VENTURES BRUSH ON BLOCK- zinc oxide 21.4% cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 16, 2021

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  • Drug Facts Active ingredients

    Zinc Oxide 21.4%

  • 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

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally (generously) 15 minutes before sun exposure
    • reapply:

       • after 80 minutes of swimming or sweating
       • immediately after towel drying
       • at least every 2 hours
    • Children under 6 months: Ask a doctor

  • Inactive Ingredients

    caprylic/capric triglyceride, carthamus
    tinctorius (safflower) seed oil, cetearyl
    alcohol, cetearyl glucoside, citric acid,
    citrus aurantium dulcis (orange) peel oil,
    citrus reticulata (tangerine) peel oil, cocos
    nucifera (coconut) oil, ethylhexylglycerin,
    galactoarabinan, glycerin, glyceryl
    laurate, glyceryl stearate, hydrogenated
    palm glycerides, isostearic acid, lecithin,
    methyl dihydroabietate, phenoxyethanol,
    polyglyceryl-10 oleate, polyglyceryl-3
    polyricinoleate, polyhydroxystearic acid,
    polysorbate 20, potassium cetyl phosphate,
    simmondsia chinensis (jojoba) seed oil,
    sodium phytate, stearyl/octyldodecyl citrate
    crosspolymer, water/aqua/eau, xanthan gum

  • QUESTIONS

    Questions or Comments?
    Call toll free 1-800-916-7690

  • BRUSHONBLOCK Labeling

    BRUSHONBLOCK​®

    NON-NANO ZINC OXIDE

    MINERAL
    SUNSCREEN
    LOTION

    UVA/UVB PROTECTION
    WATER RESISTANT 80 MIN.

    BROAD SPECTRUM SPF 30

    DIST. BY BRUSH ON BLOCK
    PORTLAND, OR 97223, USA
    MADE IN USA

    BRUSHONBLOCK.COM

    155-50

    RES

  • INGREDIENTS AND APPEARANCE
    SPF VENTURES BRUSH ON BLOCK 
    zinc oxide 21.4% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54111-155
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION21.4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
    MANDARIN OIL (UNII: NJO720F72R)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GALACTOARABINAN (UNII: SL4SX1O487)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYGLYCERYL-10 OLEATE (UNII: 55C81W76DH)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    JOJOBA OIL (UNII: 724GKU717M)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54111-155-50162 mL in 1 TUBE; Type 0: Not a Combination Product05/28/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/28/2021
    Labeler - Bentley Laboratories, LLC (068351753)
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