Label: RIVERSOL LIGHTWEIGHT BROAD SPECTRUM SUNSCREEN SPF 30- titanium dioxide, zinc oxide cream

  • 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 January 20, 2020

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  • Active Ingredients

    Zinc Oxide 10%

    Titanium Oxide 6%

  • 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 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 using and ask a doctor is rash occurs

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

  • Directions

    Apply liberally 15 minutes before sun exposure.

    Reapply at least every 2 hours.

    Use a water resistant sunscreen if swimming or sweating

    Childre under 6 months: Ask a doctor

    Sun Protection Measures. Spending time in the sun increases you risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am - 2 pm Wear long sleeve shirts, pants, hats and sunglasses.

  • Other Information

    Protect this product from excessive heat and direct sun.

  • Questions or comments?

    Call toll free 1-866-774-8377 or visit www.riversol.com

  • Principal Display Panel

    Riversol

    Dermatologist Developed fo Sensitive Skin

    Lightweight Broad Spectrum Sunscreen

    Mineral sun filters (Zn + Ti)

    Fragrance Free

    SPF 30

    Sheer Tint

    60 mL / 2 oz

    Image of box showing principal display panel

  • INGREDIENTS AND APPEARANCE
    RIVERSOL LIGHTWEIGHT BROAD SPECTRUM SUNSCREEN SPF 30 
    titanium dioxide, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72019-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE100 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.09883 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LAURIC ACID (UNII: 1160N9NU9U)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    ALCOHOL (UNII: 3K9958V90M)  
    AMINOPROPYL ASCORBYL PHOSPHATE (UNII: 290O2PQ83R)  
    DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATE (UNII: 408UEF2TE8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SORBIC ACID (UNII: X045WJ989B)  
    CAPRYLIC/CAPRIC ACID (UNII: DI775RT244)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
    HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    .BETA.-THUJAPLICIN (UNII: U5335D6EBI)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72019-0001-11 in 1 BOX01/25/2018
    160 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/25/2018
    Labeler - Riversol Skincare Solutions Inc (203514773)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natures Formulae Health Products Ltd.241385587manufacture(72019-0001)
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