Label: PRIVATE LABEL SUNSCREEN SPF35 40MIN WR RE126-202- homosalate, zinc oxide sunscreen lotion

  • NDC Code(s): 60232-0036-1
  • Packager: Swiss-American CDMO, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 9, 2023

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

View All Sections
  • 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 physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.

  • Active Ingredients

    Homosalate 9.0% Sunscreen
    Zinc Oxide 10.0% Sunscreen
    Octisalate 5.0% Sunscreen

  • uses

    Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  • uses

    Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  • Directions

    Apply liberally 15 minutes before sun exposure. Reapply after 40 minutes of swimming or sweating, immediately after towel drying and 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 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

  • Keep out of reach of children

    Keep out of reach of children

  • Other information:

    Protect this product from excessive heat and direct sun.

  • Inactive Ingredients

    Water, dimethicone, PEG-10 dimethicone, euphorbia cerifera (Candelilla) Wax, Caprylic/Capric Trigylceride, sodium chloride, phenoxyethanol, polyhydroxystearic acid, triethoxycaprylylsilane, saccharide isomerate, ethylhexylglycerin, dl-alpha tocopheryl acetate, glycerin, disodium EDTA, xanthan gum, Gossypium herbaceum (Cotton) extract, citric acid, sodium citrate, benzyl alcohol, gluconolactone, sodium benzoate, calcium gluconate

  • Questions?

    Call toll free 1-866-416-2366

  • Labeling

    PL036 Drug Facts

  • INGREDIENTS AND APPEARANCE
    PRIVATE LABEL SUNSCREEN SPF35 40MIN WR RE126-202 
    homosalate, zinc oxide sunscreen lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60232-0036
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE90 g  in 1000 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION100 g  in 1000 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GOSSYPIUM HIRSUTUM WHOLE (UNII: 0Z88765ZGC)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60232-0036-130 g in 1 PACKAGE; Type 0: Not a Combination Product11/09/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/09/2023
    Labeler - Swiss-American CDMO, LLC (080170933)
    Registrant - Swiss-American CDMO, LLC (080170933)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American CDMO, LLC080170933manufacture(60232-0036)
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!