Label: LATHER- DAILY DEFENSE MINERAL SPF 50- zinc oxide cream

  • NDC Code(s): 77394-202-01, 77394-202-13
  • Packager: Lather, Inc.
  • 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 October 3, 2023

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  • ACTIVE INGREDIENTS

    Zinc Oxide 21%

  • 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 product is 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
    • 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
    •      children under 6 months of age: ask a doctor
  • OTHER INFORMATION

    • Protect this product from excessive heat and direct sun
  • INACTIVE INGREDIENTS

    Water (aqua), Coco-Caprylate/Caprate, Cetearyl Alcohol, Propanediol, Stearyl Alcohol, Polyhydroxystearic Acid, Mica, Butyrospermum Parkii (Shea) Butter, Cetearyl Olivate, Sorbitan Olivate, Camellia Sinensis (Green Tea) Extract, Olea Europaea (Olive) Leaf Extract, Equisetum Arvense (Horsetail) Extract, Rosmarinus Officinalis (rosemary) Extract, Centella Asiatica (Gotu Kola) Extract, Aesculus Hippocastanum (Horse Chestnut) Extract, Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Glyceryl Caprylate, Glycerin, Xanthan Gum, Tocopheryl Acetate, Citrus Nobilis (Mandarin Orange) Peel Oil, Silica, Caprylhydroxamic Acid, Triethoxycaprylylsilane, Ascorbyl Palmitate, Caprylic/Capric Triglyceride, Ascorbic Acid, Tocopherol, Potassium Sorbate, Sodium Phytate, Citric Acid, Iron Oxides

  • PRINCIPAL DISPLAY PANEL

    01b UC_Daily-Defense-Mineral-SPF50_2oz_BOX_FDA2

  • INGREDIENTS AND APPEARANCE
    LATHER- DAILY DEFENSE MINERAL SPF 50 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77394-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION21 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    MICA (UNII: V8A1AW0880)  
    BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
    OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
    EQUISETUM ARVENSE WHOLE (UNII: 73DM367W4P)  
    ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M)  
    COCOS NUCIFERA WHOLE (UNII: 245J88W96L)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CITRUS NOBILIS (UNII: 8MFF77J91V)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CAPRYLIC/CAPRIC/SUCCINIC TRIGLYCERIDE (UNII: J4BY50FL78)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77394-202-131 in 1 BOX04/28/2021
    157 g in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:77394-202-0117 g in 1 BOTTLE; Type 0: Not a Combination Product04/28/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/28/2021
    Labeler - Lather, Inc. (100666606)
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