Label: 1177, 1178 SUNSCREEN cream

  • NDC Code(s): 67777-177-01, 67777-177-02, 67777-177-11
  • Packager: Dynarex
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 20, 2024

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

View All Sections
  • Active Ingredients

    Homosalate 6%, Octinoxate 7.5%, Octisalate 5%, Oxygenzone 5%

  • Purpose

    Sunscreen

  • Uses

    . Protects from excessive heat and direct sun

    . Helps prevent sunburns

    . Higher SPF gives more sunburn protection

    . For skin highly sensitive to sunburn

  • Warnings

    For External Use Only.

    Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin carcer or early skin aging.

    Do not use

    On damaged or broken skin

    When using this product

    . Keep out of eyes

    . Rinse with water to remove

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center 800-222-1222) right away.

  • Directions

    . Apply liberally 15 minutes before sun exposure

    . Reapply at least every 2 hours

    . Children under 6 months: as a doctor

  • Inactive ingredients

    Antaron V-220, Butylated Hydroxyanisole, Butylated Hydroxytoluene, Carbopol Ultrez 10, Ceteareth 20, Cetyl Alcohol, Dimethicone 350, Edetate Disodium, Glyceryl Stearate SE, Methylparaben, Propylparaben, Purified Water, Sorbitan Monostearate, Sorbitol Solution, Stearic Acid, Trolamine

  • Questions?

    1-888-DYNAREX Monday - Friday, 9AM - 5PM EST

  • Label

    1177 BX MASTER1177 Sunscreen

  • Label

    1177-1178 DM MASTER1177, 1178 Sunscreen

  • INGREDIENTS AND APPEARANCE
    1177, 1178 SUNSCREEN 
    1177, 1178 sunscreen cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-177
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE6 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
    SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Product Characteristics
    Color    Score    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-177-0124 in 1 CASE05/27/2021
    1NDC:67777-177-1125 in 1 BOX
    13.5 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:67777-177-021000 in 1 CASE05/27/2021
    23.5 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/27/2021
    Labeler - Dynarex (008124539)
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!