Label: PROTECTIVE TINTED MOISTURIZER BROAD SPECTRUM SUNSCREEN SPF 30- titanium dioxide, zinc oxide paste

  • NDC Code(s): 65278-104-01, 65278-104-02
  • Packager: June Jacobs Labs LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 20, 2024

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  • ACTIVE INGREDIENT

    Active Ingredients

    Titanium Dioxide........... 4.31%

    Zinc Oxide....................19.27%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    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

    Warnings

    For external use only

  • DO NOT USE

    Do not use on damaged or broken skin

  • WHEN USING

    • In case of contact with eyes, rinse with water
    • If rash occurs, stop use and consult a doctor
  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • Use daily after cleanser or serum for protective moisture and younger-looking skin. Apply to face and neck liberally 15 minutes before sun exposure. Reapply at least every two hours
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early 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 sleeve shirts, pants, hats and sunglasses
    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating
    • Children under 6 months: Ask a doctor
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Ethyl Macadamiate, Caprylic/Capric Triglyceride, Saccharomyces Ferment, Coco Caprylate/Caprate, Behenyl Behenate, Sorbitol/Sebacic Acid Copolymer Behenate, Polyhydroxystearic Acid, Octyldodecyl Erucate, Euphorbia Cerifera (Candelilla) Wax, Fragrance/Parfum, Lauroyl Lysine, Iron Oxides, Stearic Acid, Alumina, Glyceryl Caprylate, Butyrospermum Parkii (Shea) Butter, Persea Gratissima (Avocado) Oil , Argania Spinosa Kernel Oil, Tocopheryl Acetate, Polyglyceryl-6 Polyricinoleate, Dilinoleic Acid/Butanediol Copolymer, Tocopherol, Glyceryl Undecylenate, Malic Acid, Castor Oil/IPDI Copolymer, Glycerin, Lycium Barbarum Fruit Extract , Punica Granatum Extract, Vitis Vinifera (Grape) Seed Extract, Aspalathus Linearis Leaf Extract , Leuconostoc/Radish Root Ferment Filtrate, Camellia Sinensis Leaf Extract, Limonene, Linalool, Citral.

  • OTHER SAFETY INFORMATION

    Other information

    ■ Protect this product from excessive heat and direct sun

  • QUESTIONS

    Questions or comments?

    Call toll free 1-866-JUNEJACOBS ■ www.JUNEJACOBS.com

  • PRINCIPAL DISPLAY PANEL

    Protective tinted CartonProtective tinted Tube

  • INGREDIENTS AND APPEARANCE
    PROTECTIVE TINTED MOISTURIZER BROAD SPECTRUM SUNSCREEN SPF 30 
    titanium dioxide, zinc oxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65278-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9.693 g  in 50.28 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.169 g  in 50.28 g
    Inactive Ingredients
    Ingredient NameStrength
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    MALIC ACID (UNII: 817L1N4CKP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    JUNIPER BERRY OIL (UNII: SZH16H44UY)  
    ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
    LITSEA OIL (UNII: 2XIW34BN6O)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)  
    DILINOLEIC ACID/BUTANEDIOL COPOLYMER (UNII: 1F2S8T535O)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    VETIVER OIL (UNII: 9M9P32M01L)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    OCTYLDODECYL ERUCATE (UNII: D4N66T98C2)  
    AMYRIS BALSAMIFERA OIL (UNII: I1BJ961J2E)  
    GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
    POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO)  
    GALBANUM (UNII: C690YC9N2Z)  
    CITRAL (UNII: T7EU0O9VPP)  
    BEHENYL BEHENATE (UNII: K8NU647RJ0)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    Product Characteristics
    Colorbrown (Nude/Beige) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65278-104-0150.28 g in 1 TUBE; Type 0: Not a Combination Product09/08/2021
    2NDC:65278-104-0250.28 g in 1 CARTON; Type 0: Not a Combination Product09/08/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02009/08/2021
    Labeler - June Jacobs Labs LLC (082439410)
    Establishment
    NameAddressID/FEIBusiness Operations
    June Jacobs Labs, LLC122610681manufacture(65278-104)