Label: BURTS BEES FIRMING DAY SPF30- zinc oxide lotion

  • 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 October 31, 2022

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  • Active Ingredient

    Zinc Oxide 16.9%

    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 broken or damaged 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 product is swalloed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Reapply

    ​Sun Protection Measures

    Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly us a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in sun, especially from 10a.m.-2p.m., wear long-sleeved shirts, pants, hats and sunglasses . Children under 6 months: ask a doctor.

  • Other Information

    Protect this product from excessive hear and direct sun.

  • Inactive Ingredients:

    water, glycerin, caprylic/capric triglyceride, polyglyceryl-6 stearate, C13-15 alkane, pentylene glycol, mica, c15-19 alkane, silica, cetearyl nonanoate, inulin, squalane,  carthamus tinctorius (safflower) seed oil, cetearyl alcohol, simmondsia chinensis (jojoba) seed oil, polyhydroxystearic acid, argania spinosa kernel oil, saccharomyces ferment filtrate, tocopheryl acetate, citric acid,  hydroxyacetonphenone, ribosa, xanthan gum, polyglyceryl-6 behenate, glyceryl laurate, sodium PCA, beeswax, acacia senegal gum, bakuchiol, fragrance, sodium citrate, c12-26 alkane, sodium phytate, bisabolol, potassium sorbate, adansonia digitata fruit extract, hibiscus sabdariffa flower extract.

  • PRINCIPAL DISPLAY PANEL

    FIRMINGUC

  • INGREDIENTS AND APPEARANCE
    BURTS BEES FIRMING DAY  SPF30
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:26052-493
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION16.9 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    C13-15 ALKANE (UNII: 114P5I43UJ)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    MICA (UNII: V8A1AW0880)  
    C15-19 ALKANE (UNII: CI87N1IM01)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CETEARYL NONANOATE (UNII: F6ZWV2F361)  
    INULIN (UNII: JOS53KRJ01)  
    SQUALANE (UNII: GW89575KF9)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    JOJOBA OIL (UNII: 724GKU717M)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ACACIA (UNII: 5C5403N26O)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    HEXASODIUM PHYTATE (UNII: ZBX50UG81V)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
    ADANSONIA DIGITATA FRUIT (UNII: 51N9TR1W6P)  
    BAKUCHIOL (UNII: OT12HJU3AR)  
    RIBOSE, D- (UNII: 681HV46001)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:26052-493-011 in 1 CARTON10/01/2021
    151 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02010/01/2021
    Labeler - Burts Bees (613480946)