Label: RENOVE UV SHIELD BROAD SPECTRUM SPF 50- avobenzone, octinoxate sunscreen cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 March 7, 2017

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

View All Sections
  • Drug Facts

  • ACTIVE INGREDIENTS

    Avobenzone 3%

    Octinoxate 6.2%

    PURPOSE

    Sunscreen

  • USES

    • 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
  • 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

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    • Apply liberally 15 minutes before sun exposure.
    • Reapply after 80 minutes of swimming or sweating.
    • Immediately after towel drying
    • At least every 2 hours
    • 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 years of age: Ask a doctor.
  • INACTIVE INGREDIENTS

    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES

    DICAPRYLYL CARBONATE
    FRAGARIA VESCA FRUIT

    GLYCERIN

    SUNFLOWER SEED

    WATER
    CAPRYLHYDROXAMIC ACID
    CAPRYLYL GLYCOL

    1,2-HEXANEDIOL
    LINSEED OIL
    EVENING PRIMROSE OIL
    CHIA SEED OIL
    ACAI OIL
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE
    XANTHAN GUM
    AMARANTHUS CAUDATUS SEED
    VACHELLIA FARNESIANA WHOLE
    ORANGE
    GREEN TEA LEAF

    Acrylates

    Plankton Extract

  • OTHER INFORMATION

    Protect this product from excessive heat and direct sun.

  • Product Label

    Renove UV Shield

  • INGREDIENTS AND APPEARANCE
    RENOVE UV SHIELD BROAD SPECTRUM SPF 50 
    avobenzone, octinoxate sunscreen cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60782-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.2 g  in 10 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ORANGE (UNII: 5EVU04N5QU)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    FRAGARIA VESCA FRUIT (UNII: CG6IX3GCMU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUNFLOWER SEED (UNII: R9N3379M4Z)  
    WATER (UNII: 059QF0KO0R)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    CHIA SEED OIL (UNII: MC2LH51BO7)  
    ACAI OIL (UNII: Z0W6766A2W)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    AMARANTHUS CAUDATUS SEED (UNII: FJ722PPQ9M)  
    VACHELLIA FARNESIANA WHOLE (UNII: YPI49T6HNL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60782-003-002 in 1 BOX03/10/2017
    150 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/04/2015
    Labeler - Y.S. Health Corp. (612982504)
    Registrant - Y.S. Health Corp. (612982504)
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!