Label: SUPERSCREEN HYDRATING DAILY CREAM SPF 40- avobenzone, homosalate, octisalate, octocrylene cream

  • NDC Code(s): 75936-620-01, 75936-620-02
  • Packager: Supergoop, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 June 26, 2023

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

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredients: Avobenzone 3%, Homosalate 6%, Octisalate 5%, Octocrylene 1.5%

  • PURPOSE

    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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help, or contact a poison control center right away.

  • 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

  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs

  • DOSAGE & ADMINISTRATION

    Directions

    Apply generously and evenly 15 minutes before sun exposure

    Reapply at least every 2 hours

    Use a water resistant sunscreen if swimming or sweating

    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 a.m.- 2 p.m.

    Wear long-sleeved shirts, pants, hats, and sunglasses

    Children under 6 months: Ask a doctor

  • PRINCIPAL DISPLAY PANEL

    Superscreen Hydrating Daily Cream SPF 40 / 50 mL

    Carton

  • INGREDIENTS AND APPEARANCE
    SUPERSCREEN HYDRATING DAILY CREAM SPF 40 
    avobenzone, homosalate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-620
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE6 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.5 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ECTOINE (UNII: 7GXZ3858RY)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERYL TRIOLEATE (UNII: O05EC62663)  
    INULIN LAURYL CARBAMATE (UNII: 48RFF58ESG)  
    WATER (UNII: 059QF0KO0R)  
    POLYESTER-7 (UNII: 0841698D2F)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    APHANIZOMENON FLOSAQUAE (UNII: 49VG1X560X)  
    GLYCERYL DIOLEATE (UNII: Z3MP1W91CW)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    CERAMIDE NP (UNII: 4370DF050B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-620-021 in 1 BOX06/26/2023
    1NDC:75936-620-0150 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/26/2023
    Labeler - Supergoop, LLC (117061743)
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!