Label: CIRCADIA CIRCA-SHIELD MINERAL SUNSCREEN SPF 30- zinc oxide cream

  • NDC Code(s): 76458-401-00
  • Packager: Circadia by Dr Pugliese, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 22, 2023

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

  • Drug Facts

  • Active Ingredient

    Zinc Oxide (17.3%)

    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 to skin 15 minutes before sun exposure.

    • use a water resistant sunscreen if swimming or sweating.
    • reapply 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 Broad Spectrum SPF or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirt, pants, hats and sunglasses.
  • Inactive Ingredients

    C14-22 Alkane, Olea Europaea fruit Oil, Sorbitan Olivate, Diisopropyl Adipate, C9-12 Alkane, Silica, Oryza Sativa Bran Cera, Vegetable Oil, Simmondsia Chinensis Seed Oil, Curcuma Longa Root Extract, Saccharomyces Ferment, Polyglyceryl-4 Olivate/Polyricinoleate, Triethoxycaprylylsilane, Coco-Caprylate, Glycine Soja Oil, Polyhydroxystearic Acid, Triethyl Citrate, Lauroyl Lysine, Bis(Cyano Butylacetate) Antharacenediylidene, Polyglyceryl-3 Diisostearate, Oryza Sativa Germ Extract Oryza Sativa Extract, Caprylic /Capric Triglyceride, Camellia Sinensis Leaf Extract, Vanila Planifolia Fruit Extract, Salvia Officinalis Flower/Leaf/Stem Extract, Rosmarinus Officinalis Leaf Extract, Lavandula Angustifolia Flower/Leaf/Stem Extract, Salvia Triloba Leaf Extract, Jasminum Officinale Flower/Leaf Extract, Rosa Damascena Flower Extract, Linalool.

  • Other information

    protect this product from excessive heat and direct sun.

  • Questions?

    Call toll-free (800) 630-4710

  • Package Labeling:

    Inner Label
    Outer Label
  • INGREDIENTS AND APPEARANCE
    CIRCADIA CIRCA-SHIELD MINERAL SUNSCREEN SPF 30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76458-401
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION173 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
    C9-12 ALKANE (UNII: 7J5R5W72QM)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TURMERIC (UNII: 856YO1Z64F)  
    POLYGLYCERYL-4 OLIVATE/POLYRICINOLEATE (UNII: WYX2KZL5BD)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    VANILLA BEAN (UNII: Q74T35078H)  
    ROSEMARY (UNII: IJ67X351P9)  
    LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    THREE-LOBE SAGE (UNII: 3V97D33N0K)  
    JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
    ROSA X DAMASCENA FLOWER (UNII: JWB78P295A)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76458-401-001 in 1 BOX12/31/2023
    159 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/31/2023
    Labeler - Circadia by Dr Pugliese, Inc. (013694423)