Label: REN CLEAN FAVOURITES- zinc oxide kit

  • 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 December 28, 2021

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  • Drug Facts

  • Active ingredients

    Zinc Oxide 22%

    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.

    Stop use and ask a doctor if

    • Rash occurs.

    Keep out of reach of children.

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

  • Directions

    • Apply liberally 15 minutes before sun exposure 
    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating
    • 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. - 2p.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

    Aqua (Water), Caprylic/Capric Triglyceride, Aloe Barbadensis Leaf Juice, Glycerin, Caprylyl Caprylate/Caprate, Propanediol, Arachidyl Alcohol, Cetearyl Alcohol, Coco-Glucoside, Oryza Sativa Starch, Pongamia Glabra Seed Oil, Microcrystalline Cellulose, Behenyl Alcohol, Phenoxyethanol, Arachidyl Glucoside, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Passiflora Edulis Fruit Extract, Ethylhexylglycerin, Glyceryl Oleate, Vaccinium Macrocarpon (Cranberry) Seed Oil, Xanthan Gum, Cellulose Gum, Sodium Chloride, HippophaeRhamnoides Oil, Citrus Nobilis (Mandarin Orange) Peel Oil, Anthemis Nobilis Flower Oil, Cinnamomum Camphora Linalloliferum Wood Oil, Pelargonium Graveolens Flower Oil, Glucose, Parfum* (Fragrance), Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Rosmarinus Officinalis (Rosmary) Leaf Extract, Hydrogenated Palm Glycerides Citrate, Citric Acid, Sodium Hydroxide, Citronellol, Geraniol, Limonene, Linalool

    *100% Natural Fragrance - Parfum 100% Naturel

  • Questions or comments?

    please contact 800-437-3488 from 8:30-17:30 EST

  • Package Labeling: 51417-0003-1

    Kit

  • Package Labeling: 51417-0002-5

    BoxInner Package.

  • INGREDIENTS AND APPEARANCE
    REN CLEAN FAVOURITES 
    zinc oxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51417-0003
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51417-0003-11 in 1 KIT09/01/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 10 mL
    Part 1 of 1
    CLEAN SCREEN MINERAL SPF30 MATTIFYING FACE SUNSCREEN BROAD SPECTRUM 
    zinc oxide cream
    Product Information
    Item Code (Source)NDC:51417-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION220 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    STARCH, RICE (UNII: 4DGK8B7I3S)  
    KARUM SEED OIL (UNII: 62160PU6FJ)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    CRANBERRY SEED OIL (UNII: 73KDS3BW5E)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    MANDARIN OIL (UNII: NJO720F72R)  
    CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
    PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51417-0002-11 in 1 BOX
    110 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2019
    Labeler - REN Ltd (385613831)
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