Label: JOUVALLE DEEP NOURISHING LUMINOSITY DAY- octinoxate, homosalate, octisilate, oxybenzone and avobenzone cream

  • Category: HUMAN OTC DRUG LABEL

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 26, 2021

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  • Active Ingredients

    Octinoxate    7.40%
    Homosalate  6.20%
    Octisalate     5.20%
    Oxybenzone 3.10%
    Avobenzone 1.50%

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn.
  • Warnings

    For external use only. Do not use on damaged or broken skin.

    Keep out of eyes. If contact occurs, rinse with water. If rash or irritation develops, discontinue use and consult your physician.

  • Stop using this product and ask doctor if redness develops and lasts.

  • Keep out of reach of children.

    If accidental ingestion, call the Poison Control Center right away.

  • Directions

    After cleansing, apply liberally and evenly 15 minutes before sun exposure. Smooth over face and neck and chest daily for optimal results.
    Reapply at least every two (2) hours.
    Use 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. – 2 p.m.
    wear long-sleeved shirts, pants, hats and sunglasses

    For children under 6 months of age: Ask doctor.

  • Other Information

    Protect the product in this container from excessive heat and direct sun. Store at room temperature.

  • Inactive Ingredients

    Aqua, C12-15 Alkyl Benzoate, Glycerin, Glyceryl Stearate, Stearic Acid, PEG-100 Stearate, Tocopherol, Retinyl Palmitate, Sodium Hyaluronate, Euterpe Oleracea Fruit Extract, Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf Extract, Sodium PCA, Polysorbate 60, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Disodium EDTA, Phenoxyethanol, Ethylhexylglycerin.

  • Package/Label Principal Display Panel

    JOUVALLE™

    DEEP NOURISHING
    LUMINOSTIY DAY CREAM
    BROAD SPECTRUM SPF30

    Acai STEM CELLS & HYALURONIC ACID

    50g / 1.76oz

    image-01

    Label

  • INGREDIENTS AND APPEARANCE
    JOUVALLE DEEP NOURISHING LUMINOSITY DAY 
    octinoxate, homosalate, octisilate, oxybenzone and avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73191-125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.4 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE6.2 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.2 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3.1 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    MYRISTIC ACID (UNII: 0I3V7S25AW)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ACAI (UNII: 46AM2VJ0AW)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73191-125-191 in 1 CARTON08/01/2019
    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 finalpart35208/01/2019
    Labeler - Florida Private Labeling LLC (081081732)