Label: CLEAR SUNSCREEN SPF 30 BROAD SPECTRUM- avobenzone, homosalate, octisalate, octocrylene gel

  • Category: HUMAN OTC DRUG LABEL

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 7, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active ingredients Purpose

    Avobenzone 3% Sunscreen

    Homoslatate 15% Sunscreen

    Octisalate 5% Sunscreen

    Octocrylene 2.79% Sunscreen

  • PURPOSE

    Uses

    • Helps prvent 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.
  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs.

  • WARNINGS

    Warnings

    • For external use only
    • Do not use on broken or damaged skin
    • When using this product keep out of eyes. Rinse with water to remove.
  • DOSAGE & ADMINISTRATION

    Directions

    • Apply liberally 15 minutes before sun exposure
    • Reapply:
    • After 40 minutes of swimming or sweating
    • at least every 2 hours
    • Sun Protections 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 am- 2pm
    • wear long-sleeve shirts, pants, hats, and sunglasses
    • Children under 6 months: Ask a doctor
  • INACTIVE INGREDIENT

    Inactive ingredients Butyloctyl Salicylate, Capric/Caprylic Triglyceride, Dicaprylyl Ether, DImethicone/Bis-Isobutyl PPG-20 Crosspolymer, Fragrance, Isododecane, Methyl Dihydroabietate, Silica.

  • PRINCIPAL DISPLAY PANEL

    Cremo Clear Sunscreen

    for face, hairline & Scalp

    SPF 30 Broad Spectrum

    2 FL OZ (59mL)

    Box

    label

  • INGREDIENTS AND APPEARANCE
    CLEAR SUNSCREEN SPF 30 BROAD SPECTRUM 
    avobenzone, homosalate, octisalate, octocrylene gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71825-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.79 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISODODECANE (UNII: A8289P68Y2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71825-101-0159 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/07/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/07/2019
    Labeler - Cremo company (078708508)
    Establishment
    NameAddressID/FEIBusiness Operations
    Raining Rose, Inc.083819404manufacture(71825-101)
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

More Info on this Drug

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