Label: MOTHER SPF - DAILY FACE AND BODY SPF30 BROAD SPECTRUM- zinc oxide lotion

  • 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 December 31, 2020

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  • ACTIVE INGREDIENT

    ZINC OXIDE  19.5%

  • PURPOSE

    SUNSCREEN

  • USE

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin ageing 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.
  • DIRECTIONS

    • Apply generously 15 minutes before sun exposure.
    • Reapply after 80 minutes of swimming or sweating.
    • Reapply immediately after towel drying.
    • Reapply at least every 2 hours.
    • 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 10.00AM - 2.00PM
    • Wear long-sleeved shirts, pants, hats, and sunglasses”
  • INACTIVE INGREDIENTS

    Coco-Caprylate/Caprate (ECOCERT) (and) Polyglyceryl-3 Polyricinoleate (ECOCERT) (and) Isostearic Acid (ECOCERT), Caprilic Capric Triglyceride (SUSTAINABLY SOURCED), Coconut Oil (ACO), Castor Oil (ACO), Candellila Wax, Dl Alpha Tocopheryl Acetate (SUSTAINABLY SOURCED)

  • OTHER INFORMATION

    Protect the product in this container from excessive heat and direct sun.
    For expiration date see crimp of tube.

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Mother Sun SPF-30

  • INGREDIENTS AND APPEARANCE
    MOTHER SPF - DAILY FACE AND BODY SPF30 BROAD SPECTRUM 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73204-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION19.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    Isostearic Acid (UNII: X33R8U0062)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    Coconut Oil (UNII: Q9L0O73W7L)  
    Castor Oil (UNII: D5340Y2I9G)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73204-101-11120 g in 1 TUBE; Type 0: Not a Combination Product08/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/01/2019
    Labeler - MOTHER SUN PROTECTION FACTOR PTY LTD (745449142)
    Establishment
    NameAddressID/FEIBusiness Operations
    WILD CHILD W A PTY LTD744660692manufacture(73204-101)
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