Label: RIVERSOL SPF 40 WEIGHTLESS BODY SUNSCREEN- weightless body sunscreen 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 December 30, 2020

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

  • ACTIVE INGREDIENT

    Zinc Oxide 20.5%

  • PURPOSE

    Sunscreen

  • 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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • WHEN USING

    Apply liberally to face and body 15 minutes before sun exposure.Reapply after 40 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hours.Children under 6 months: 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 15 value or higher along with 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.

  • PRECAUTIONS

    Protect the product in this container from excessive heat and direct sunstore at room temperature 59-86°F (15-30°C)May stain some fabrics.

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    RIversol

    Weightless Body Sunscreen

    Broad spectrum, hypoallergenic lotion

    SPF 40 UVA / UVB protection

    Rubs in Clear, Non-whitening

    Fast absorbing, Fragrance-Free

    Reef-Safe, Mineral Sun Filter (Zinc Oxide)

    Water / Sweat Resistant (40 MIN)

    nt wt. 140g (4.9 oz) Display

  • INGREDIENTS AND APPEARANCE
    RIVERSOL SPF 40 WEIGHTLESS BODY SUNSCREEN 
    weightless body sunscreen cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72019-0004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    METHYLCELLULOSE (100 CPS) (UNII: 4GFU244C4J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
    GINKGO BILOBA WHOLE (UNII: 660486U6OI)  
    CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
    BAMBUSA ARUNDINACEA STEM (UNII: NRA4497HC5)  
    POLYGLYCERYL-4 OLEATE (UNII: 15B05TY4GX)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)  
    SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)  
    JOJOBA OIL (UNII: 724GKU717M)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    POPULUS TREMULOIDES BARK (UNII: 5543O0CEID)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    OCTYLDODECYL LACTATE (UNII: 8JKW8M5W35)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM LAURYL GLYCOL CARBOXYLATE (UNII: 8L0472VMYL)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DILAURYL CITRATE (UNII: 5OYS3G306B)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72019-0004-11 in 1 BOX06/01/2020
    1140 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2020
    Labeler - Riversol Skincare Solutions Inc (203514773)