Label: REVIVE SENSITIF RENEWAL DAILY CELLULAR PROTECTION BROAD SPECTRUM SPF 30 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone 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 January 18, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Avobenzone 3.0%Sunscreen
    Homosalate 10.0%Sunscreen
    Octisalate 5.0%Sunscreen
    Octocrylene 1.0%Sunscreen
    Oxybenzone 5.0%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.

    Stop use and ask a doctor if rash occurs.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

     

      • For sunscreen use:
      • apply liberally 15 minutes before sun exposure
      • use a water resistant sunscreen if swimming or sweating
      • reapply 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 months of age: Ask a doctor
  • Other information

    Protect the product in this container from excessive heat and direct sun.

  • Inactive ingredients

    Water, Butylene Glycol, Glyceryl Stearate, Cetearyl Alcohol, Glycerin, Potassium Cetyl Phosphate, Stearic Acid, Oligopeptide-24, Polysorbate 60, Polyester-8, Sclerotium Gum, Bisabolol, Phenoxyethanol, Dimethicone, Sodium PCA, Squalane, Tocopheryl Acetate, Helianthus Annuus (Sunflower) Seed Oil, Persea Gratissima (Avocado) Oil, Allantoin, Caprylyl Glycol, Phytosterols, Chlorphenesin, Olea Europaea (Olive) Fruit Oil, Disodium EDTA, Glycolipids, Sodium Hyaluronate, Citrus Aurantium Dulcis (Orange) Oil, Zingiber Officinale (Ginger) Root Extract, Tocopherol, Citral, Linalool, Limonene.

  • Questions or comments?

    Call 1-866-986-7083, M – F 8am – 5pm CST.

  • PRINCIPAL DISPLAY PANEL - 50 g Jar Carton

    SENSITIF™
    RENEWAL CREAM

    RéVive

    Daily Cellular Protection
    Broad Spectrum SPF 30 Sunscreen

    50 g / net wt. 1.7 oz.

    PRINCIPAL DISPLAY PANEL - 50 g Jar Carton
  • INGREDIENTS AND APPEARANCE
    REVIVE SENSITIF RENEWAL   DAILY CELLULAR PROTECTION BROAD SPECTRUM SPF 30 SUNSCREEN
    avobenzone, homosalate, octisalate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-419
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 mg  in 1 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    SQUALANE (UNII: GW89575KF9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    GINGER (UNII: C5529G5JPQ)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CITRAL (UNII: T7EU0O9VPP)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-419-501 in 1 CARTON09/01/2013
    150 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35209/01/2013
    Labeler - RéVive Skincare (193691821)
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