Label: SHEER MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide cream

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

Drug Label Information

Updated December 13, 2023

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

  • ACTIVE INGREDIENT

    Active Ingredients:

    Zinc Oxide 18.6%

  • PURPOSE

    Purpose: Sunscreen

  • INDICATIONS & USAGE

    Uses • helps to 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

    Warnings For external use only

  • DO NOT USE

    Do not use • on damaged or broken skin.

  • WHEN USING

    When using this product • keep out of eyes. Rinse with warm water to remove.

  • STOP USE

    Stop use and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help, or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions • Apply liberally 15 minutes before sun exposure.

    • Children under 6 months: Ask a doctor

    • Reapply: at least every 2 hours

    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 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-sleeve shirts, pants, hats, and sunglasses.

  • OTHER SAFETY INFORMATION

    Other information • Protect this product from excessive heat or direct sun.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water (Aqua),Cyclopentasiloxane, Butylene Glycol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Cyclohexasiloxane, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Sorbitan Stearate, Dimethicone,Ascorbic Acid, Plankton Extract, Tocopherol, caprylyl Glycol, Caprylic/Capric Triglyceride, Phoenix Dactylifera ( Date) Fruit Extract, Imperata Cylindrica Root Extract, Arabidopsis Thaliana Extract, Ascorbyl Palmitate, Polygonum Aviculare Extract,Tocopheryl Linoleate/Oleate, Teprenone, Xanthan Gum,Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol, Ethylhexylglycerin, Hexylene Glycol, PEG-8, Carbomer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Cetyl Alcohol, Lecithin, Citric Acid, Sodium Lactate, Disodium EDTA, Dipotassium Glycyrrhizate, Micrococcus Lysate.

  • PRINCIPAL DISPLAY PANEL

    Sheer Mineral Sunscreen BS SPF 30

  • INGREDIENTS AND APPEARANCE
    SHEER MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4242
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE18.6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)  
    TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    DATE (UNII: H3O7QI5HY7)  
    POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
    TEPRENONE (UNII: S8S8451A4O)  
    POLYACRYLAMIDE (CROSSLINKED; 2 MOLE PERCENT BISACRYLAMIDE) (UNII: 9FPL31B58Q)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)  
    LAURETH-7 (UNII: Z95S6G8201)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM LACTATE, L- (UNII: P2Y1C6M9PS)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    MICROCOCCUS LUTEUS (UNII: LV6L29Z6AX)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4242-156.7 g in 1 TUBE; Type 0: Not a Combination Product12/13/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/13/2023
    Labeler - Allure Labs (926831603)
    Registrant - Allure Labs (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs926831603manufacture(62742-4242)