Label: FACIAL WITH PLACENTA PROTEIN SPF-15- titanium dioxide oil

  • 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 6, 2016

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

View All Sections
  • ACTIVE INGREDIENT

    Titanium Dioxide 5%

  • PURPOSE

    SUNSCREEN

  • USES

    Helps prevent sunburn.

  • WARNINGS

    If rash occurs stop use and seek medical attention. Do not use on broken or damaged skin. When using this product keep out of eyes. Rinse with water to remove. If swallowed, get medical help or contact a poison control center right away. For external use only. Keep out of reach of children.

    Sun Alert
    Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

  • DIRECTIONS

    Apply generously 15 minutes before sun exposure. Reapply at least every 2 hours. For use on children less than 6 months of age, consult a health care professional. Use a water resistant sunscreen if swimming or sweating.

  • INACTIVE INGREDIENTS

    Dimethicone, Dimethicone Crosspolymer, Petrolatum, Triisostearin, Glyceryl Behenate, Tocopheryl Acetate, Aluminum Hydroxide, Stearic Acid, Aloe Barbadensis Leaf Extract, Placental Protein, Fragrance

  • PRINCIPAL DISPLAY PANEL

    Facial Oil w-Placenta Protein SPF-15 (Aloe_180)_Label

    Facial Oil w-Placenta Protein SPF-15 (Avocado_180)_Label

    Facial Oil w-Placenta Protein SPF-15 (Royal Jelly_180)_Label

    Facial Oil w-Placenta Protein SPF-15 (Vit E_180)_Label

    Placenta Oil SPF15 Drug Facts Box

  • INGREDIENTS AND APPEARANCE
    FACIAL WITH PLACENTA PROTEIN  SPF-15
    titanium dioxide oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70314-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    TRIISOSTEARIN (UNII: 71503RH8KG)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    OVIS ARIES PLACENTA (UNII: 5OEF04MP23)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70314-201-1190 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2015
    2NDC:70314-201-21180 mL in 1 BOTTLE; Type 0: Not a Combination Product12/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/01/2015
    Labeler - BILL BEAUTY AND HEALTH PRODUCTS LTD (209283592)
    Establishment
    NameAddressID/FEIBusiness Operations
    BILL BEAUTY AND HEALTH PRODUCTS LTD209283592manufacture(70314-201)
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!