Label: RAIN OR SHINE- octinoxate homosalate octisalate titanium dioxide 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 October 19, 2020

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

View All Sections
  • Active ingredients

    Octinoxate, Homosalate, Octisalate, titanium dioxide

  • PURPOSE

    Purpose: Sunscreen

  • Inactive Ingredients

    Water, Pentylene Glycol, Methylpropanediol, Caprylyl Methicone, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Isononyl Isononanoate, Ethylhexyl Triazone, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, Cyclopentasiloxane, Phenoxyethanol, Sodium Acrylate/Sodium   Acryloyldimethyl Taurate Copolymer, Isohexadecane, Aluminium Hydroxide, Stearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Tocopheryl Acetate (Vitamin E), Sorbitan Isostearate, Ammoniumacryloyldimethyl Taurate/VP Copolymer, Allantoin, Polysorbate 80, Butylene Glycol, Sorbitan Oleate, BHT Xanthan Gum, Biosaccharide Gum-4, Sodium Hyaluronate, Moringa Seed Oil, Ethylhexylglycerin, Green Tea Extract, Licorice Root Extract, Panax Ginseng Root Extract, Fragrance

  • 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 every 2 hours and after swimming. Children under 6 months: Ask a doctor.

    Sun Protection Measures: Sun exposure increases your risc of skin cancer and early skin aging. Use a sunscreen with a minium Broad Spectrum SPF15+ Limit time in the Sun, especially from 10 am - 2pm, wear hats, sunglasses, long-sleeve, clothing and pants. 

  • KEEP OUT OF REACH OF CHILDREN

  • Other Information:

    Protect this product from excessive heat and direct sun.

  • PRINCIPAL DISPLAY PANEL

    RAIN OR SHINE-1

    AIN OR SHINE-2

  • INGREDIENTS AND APPEARANCE
    RAIN OR SHINE 
    octinoxate homosalate octisalate titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73072-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE3 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    BEMOTRIZINOL (UNII: PWZ1720CBH)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4)  
    LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    ALLANTOIN (UNII: 344S277G0Z)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73072-002-0160 mL in 1 TUBE; Type 0: Not a Combination Product07/25/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/25/2019
    Labeler - Jaxon Lane, Inc. (114672469)
    Registrant - Jaxon Lane, Inc. (114672469)
    Establishment
    NameAddressID/FEIBusiness Operations
    EYESOME. Co.,Ltd.557795360manufacture(73072-002)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!