Label: SONAGE ROUX TINTED DAY CREME WITH SPF 30 SHEER TINTED MOISTURIZER- zinc oxide lotion

  • NDC Code(s): 69546-313-02
  • Packager: ASA Universal Inc. dba: Sonage
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2024

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  • ACTIVE INGREDIENT

    Zinc Oxide - 13.0%

  • 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

    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.

    Use a water resistant sunscreen if swimming or sweating

    Rapply at least every 2 hours.

    Children under 6 monts: Ask a doctor.

    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. to 2 p.m. Wear long-sleeved shirts, pants, hats, and sun glasses.

  • Inactive Ingredients

    Arachidyl Alcohol, Arachidyl Glucoside, Astrocaryum Tucuma Seed Butter, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Leaf Extract, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cedrus Alantica Wood (Cedarwood) Oil, Ceramide NP, Cetearyl Alcohol, Cetyl Palmitate, Citric Acid, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Coco-Glucoside, Ethyl Ferulate, Glycerin, Iron Oxides, Neopentyl Glycol Diheptanoate, Niacinamide, Octyldodecyl Oleate, Palmitoyl Hexapeptide-12, Pogostemon Cablin (Patchouli) Oil, Polyhydroxystearic Acid, Propanediol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Sorbitan Olivate, Sorbitan Palmitate, Squalane, Tocopherol, Trehalose, Water, Xanthan Gum

  • Other Information

    Protect this product from excessive heat and direct sun.

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    SONAGE ROUX TINTED DAY CREME WITH SPF 30  SHEER TINTED MOISTURIZER
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69546-313
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TREHALOSE (UNII: B8WCK70T7I)  
    SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETYL PALMITATE (UNII: 5ZA2S6B08X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SQUALANE (UNII: GW89575KF9)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    CERAMIDE NP (UNII: 4370DF050B)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    ASTROCARYUM ACULEATUM SEED OIL (UNII: JUP28JPX3K)  
    PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO)  
    CEDRUS ATLANTICA WOOD OIL (UNII: JEX140NPX8)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69546-313-021 in 1 CARTON06/08/2023
    150 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/08/2023
    Labeler - ASA Universal Inc. dba: Sonage (054687895)