Label: DR. BRANDT SUN SHIELD SPF 50- zinc oxide liquid

  • 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 February 15, 2021

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

  • Drug Facts

  • Active Ingredients

    Zinc Oxide 17%

  • 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 generously and evenly 15 minutes before sun exposure
    • Children under 6 months of age: 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 10 a.m. - 2 p.m.
    • Wear long-sleeved shirts, pants, hats and sunglasses.
    • Reapply at least every 2 hours.
    • Use a water resistant sunscreen if swimming or sweating.
  • Other Information

    Protect the product in this container from excessive heat and direct sun

  • Inactive Ingredients

    Water, Isododecane, Polyglyceryl-6 Polyricinoleate, Propanediol, Dimethicone, Caprylic/Capric Triglyceride, Trimethylsiloxysilicate, Butyloctyl Salicylate, Coco-Caprylate/Caprate, Isoamyl Laurate, Neopentyl Glycol Diheptanoate, Polyglyceryl-10 Dioleate, Lecithin, Polyhydroxystearic Acid, Ectoin, Polymethylsilsesquioxane, Polysilicone-11, Disteardimonium Hectorite, Butyrospermum Parkii (Shea) Butter, Glycerin, Phenoxyethanol, Propylene Carbonate, Aminomethyl Propanol, Citrus Aurantium Dulcis (Orange) Peel Oil, Ethylhexylglycerin, Polysorbate 20, Sclareolide, Tocopheryl Acetate, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Linalool, Linalyl Acetate, Plankton Extract, Lavandula Angustifolia (Lavender) Oil, Lavandula Hybrida Oil, Decyl Glucoside, Sodium Ascorbate, Caprylyl Glycol, Hexylene Glycol, Tocopherol

  • SPL UNCLASSIFIED SECTION

    take the doctor home

    bright this wayTM

    daily brightening mineral sunscreen

    UVA/UVB protection

    broad spectrum SPF 50

    brighten skin tone

    help protect skin against pollution and free radicals

    hydrate

    Dermatologist tested

    Non comedogenic

    No white residue

    This lightweight, 100% mineral sunscreen, formulated with non-nano zinc oxide and brightening agents not only defends against UVA/UVB rays with an SPF 50 but also features extremolyte technology which helps protect skin from HEV/blue light from devices, infrared radiation and pollution. Clary Sage and Plankton extract help protect against hyperpigmentation, reduce the look of existing age spots and even skin tone for a brighter, more youthful looking appearance.

    dr. brand® recommends: Shake well before use. Apply daily to face, neck and chest, as the last step in your skincare routine.

    ALL SKIN TYPES

    Distributed by :

    Cosmetic Dermatology LLC, Miami, FL 33172

    In the US call 800-234-1066

    Quatre S Cosmetics 75468 Paris Cedex 10 • France

    Made in U.S.A. 

    DRBRANDTSKINCARE.COM

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    DR. BRANDT SUN SHIELD SPF 50 
    zinc oxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81568-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION17 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
    ISOAMYL LAURATE (UNII: M1SLX00M3M)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    POLYGLYCERYL-10 DIPALMITATE (UNII: 84VD0IA2S6)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ECTOINE (UNII: 7GXZ3858RY)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SCLAREOLIDE (UNII: 37W4O0O6E6)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    DIMETHICONOL (600000 CST) (UNII: RKI3S914RT)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    LINALYL ACETATE (UNII: 5K47SSQ51G)  
    CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81568-101-501 in 1 BOX02/15/2021
    150 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/15/2021
    Labeler - Dr. Brandt (361999386)