Label: SUN BLOCK- octyl methoxycinnamate benzophenone-3 titanium dioxide homosalate cream

  • NDC Code(s): 51414-201-01, 51414-201-02, 51414-201-03, 51414-201-04, view more
    51414-201-05, 51414-201-06, 51414-201-07, 51414-201-08, 51414-201-09, 51414-201-10, 51414-201-11, 51414-201-12, 51414-201-13, 51414-201-14, 51414-201-15
  • Packager: Yuyao Jessie Commodity Co.,Ltd.
  • 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 January 5, 2018

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

View All Sections
  • Active Ingredient

    OctylMethoxycinnamate,Benzophenone-3,Homosalate, Titanium dioxide

  • Use

    Protection from the sun’s damaging effects

  • Warnings

    For external use only

    Not recommended for children under 6 months of age

  • Direction

    Apply liberally and evenly before sun exposure.

  • Inactive Ingredient

    Water,CetearylAlcohol,Glycerinmonostearate,

    Gctt,Propylparaben,Methylparaben,

    glycerol,EDTA-2NA,Vinylchloride-methylacrylate,

    copolymer,Methylisothiazolinone

  • PRINCIPAL DISPLAY PANEL

    label of sunscreen
  • INGREDIENTS AND APPEARANCE
    SUN BLOCK 
    octyl methoxycinnamate benzophenone-3 titanium dioxide homosalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51414-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE8 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE7.5 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE8 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETEARYL NONANOATE (UNII: F6ZWV2F361)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCEROL FORMAL (UNII: 3L7GR2604E)  
    VINYL CHLORIDE (UNII: WD06X94M2D)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    DIGLYCERIN MONOSTEARATE (UNII: E3XK1VOF1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51414-201-0115 g in 1 BOTTLE; Type 0: Not a Combination Product01/10/2018
    2NDC:51414-201-0220 g in 1 BOTTLE; Type 0: Not a Combination Product01/10/2018
    3NDC:51414-201-0330 g in 1 BOTTLE; Type 0: Not a Combination Product01/10/2018
    4NDC:51414-201-0440 g in 1 BOTTLE; Type 0: Not a Combination Product01/10/2018
    5NDC:51414-201-0550 g in 1 BOTTLE; Type 0: Not a Combination Product01/10/2018
    6NDC:51414-201-0660 g in 1 BOTTLE; Type 0: Not a Combination Product01/10/2018
    7NDC:51414-201-0770 g in 1 BOTTLE; Type 0: Not a Combination Product01/10/2018
    8NDC:51414-201-0880 g in 1 BOTTLE; Type 0: Not a Combination Product01/10/2018
    9NDC:51414-201-0990 g in 1 BOTTLE; Type 0: Not a Combination Product01/10/2018
    10NDC:51414-201-10100 g in 1 BOTTLE; Type 0: Not a Combination Product01/10/2018
    11NDC:51414-201-11200 g in 1 BOTTLE; Type 0: Not a Combination Product01/10/2018
    12NDC:51414-201-12250 g in 1 BOTTLE; Type 0: Not a Combination Product01/10/2018
    13NDC:51414-201-13300 g in 1 BOTTLE; Type 0: Not a Combination Product01/10/2018
    14NDC:51414-201-14400 g in 1 BOTTLE; Type 0: Not a Combination Product01/10/2018
    15NDC:51414-201-15500 g in 1 BOTTLE; Type 0: Not a Combination Product01/10/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/30/2010
    Labeler - Yuyao Jessie Commodity Co.,Ltd. (529892305)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yuyao Jessie Commodity Co.,Ltd. 529892305manufacture(51414-201)
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!