Label: BEAUTYCOUNTER COUNTERSUN MINERAL SUNSCREEN SPF30- zinc oxide stick

  • NDC Code(s): 69026-363-01, 69026-363-02
  • Packager: Beauty Counter, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 November 3, 2022

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  • Acttive Ingredient

    Zinc Oxide - 15.4%

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions), decreases the rist 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
    • After 80 minutes of swimming or sweating
    • Immediately after towel drying
    • At least every 2 hours.
    • Children under 6 months: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 10AM-2PM.
    • Wear long sleeved shirts, pants, hats and sunglasses.
  • Other Information

    • Protect the product in this container from excessive heat and direct sun
    • Store at room temperatures below 90 degrees Fahrenheit.
  • Inactive Ingredients

    Aloe Barbadensis Leaf Extract, Beeswax, Butyrospermum Parkii (Shea ) Butter, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Nonanoate, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Medica Limonum (Lemon) Peel Oil, Citrus Reticulata (Tangerine) Fruit Extract, Citrus Reticulata (Tangerine) Peel Oil, Coco-Caprylate, Coco-Caprylate/Caprate, Coconut Alkanes, Cocos Nucifera (Coconut) Oil, Cucurbita Pepo (Pumpkin) Seed Oil, Eschscholzia Californica Leaf Cell Extract, Euphorbia Cerifera (Candelilla) Wax, Euterpe Oleracea Fruit Oil,
    Glycerin, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Seed Oil, Isostearic Acid, Lauryl Laurate, Lecithin, Mentha Piperita (Peppermint) Oil, Mica, Mimosa Tenuiflora Bark Extract, OxyRelax California Poppy S-Gly, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Punica Granatum (Pomegrante) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Silica, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol

  • PRINCIPAL DISPLAY PANEL

    Stickspf30

  • INGREDIENTS AND APPEARANCE
    BEAUTYCOUNTER COUNTERSUN MINERAL SUNSCREEN   SPF30
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69026-363
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION15.4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    CETEARYL NONANOATE (UNII: F6ZWV2F361)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    LEMON OIL (UNII: I9GRO824LL)  
    MANDARIN OIL (UNII: NJO720F72R)  
    TANGERINE (UNII: KH3E3096OO)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    PUMPKIN SEED OIL (UNII: 6E5QR5USSP)  
    ESCHSCHOLZIA CALIFORNICA (UNII: 9315HN272X)  
    EUTERPE OLERACEA WHOLE (UNII: Y57H6218HP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    LAURYL LAURATE (UNII: GPW77G0937)  
    EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    MICA (UNII: V8A1AW0880)  
    MIMOSA TENUIFLORA BARK (UNII: 515MQE449I)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69026-363-021 in 1 CARTON06/07/2018
    1NDC:69026-363-0115 g in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/07/2018
    Labeler - Beauty Counter, LLC (070346240)
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