Label: SUNSCREEN KARINA SKIN CARE MOIST- octinoxate, zinc oxide emulsion

  • NDC Code(s): 35192-033-16
  • Packager: CA-Botana International
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 8, 2024

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Octinoxate 7.5%.............................................Sunscreen

    Zinc Oxide 7.0%............................................. Sunscreen

  • Purpose

    Sunscreen

  • Ask Doctor

    Stop use and ask a doctor if rash occurs

  • Keep out of reach of children

    Keep out of reach of children

  • Inactive Ingredients

    Water (Aqua), Glycerine, Cetearyl isononanoate, Coco caprylate caprate, Prunus amygdalus dulcis (Sweet Almond) oil, Caprylic/Capric triglyceride, Cetyl alcohol, Propanediol, Aloe barbadensis leaf extract, Ascorbic acid, Ascorbyl palmitate, Olea europaea (Olive) leaf , Potassium sorbate, Rosmarinus officinalis (Rosemary) leaf, Tocopherol, Xanthan gum, Citric acid, Ethylhexylglycerin, Phenoxyethanol, Acrylates C10-30 Alkyl Acrylate Crosspolymer,Alpha Acetyl Tetrapeptide - 5, Butyloctyl Salicylate, Camellia sinensis (White tea) Leaf extract, Cetearyl Alcohol, Ceteareth-20, Chamomillla recutita (Matricaria)Flower extract, Emulsifying wax, Ethyl Ferulate, Euterpe Oleracea (Acai) Fruit extract, Ginkgo Biloba leaf extract, Juniperus communis (Juniper) Fruit, Malpighia punicifolia (Acerola) Fruit extract, Simmondsia chinensis (Jojoba) Seed oil, Sodium Phytate. Tocopheryl Acetate, Triethoxycaprylylsilane.

  • Safety information

    Protect this product from excessive heat and direct sun

  • Dosage & Administration

    Helps prevent sunburn. If used as directed with other sun protection measured decreases the risk of skin cancer and early skin aging caused by the sun. Apply liberally 15 minutes before sun exposure. Usea water resistant sunscreen if swimming or sweating. Reapply : at least 2 hours. Children under 6 months: Ask a doctor. Sun protections measurements. 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 of 15 or higher and othe sun protection measures including: limit time in the sun, specially from 10 a.m.- 2 p.m Wear long-sleeveshirts, pants, hats, and sunglasses. Protect this product from excessive heat and direct 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. If product is swallowed get medical help or contact a poison Control Center right away.

  • Indications & Usage

    Apply liberally 15 minutes before exposure, use water resistant sunscreen, if swimming or sweating. reapply at least every 2 hours. Children under 6 months: ask a doctor

  • PRINCIPAL DISPLAY PANEL

    KarinaJPEG.jpg

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN KARINA SKIN CARE MOIST 
    octinoxate, zinc oxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35192-033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9.919 g  in 141.7 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE10.62 g  in 141.7 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02)  
    JUNIPERUS COMMUNIS STEM (UNII: HBU87MH6OY)  
    ROSEMARY (UNII: IJ67X351P9)  
    HEXASODIUM PHYTATE (UNII: ZBX50UG81V)  
    POLAWAX POLYSORBATE (UNII: Q504PL8E0V)  
    ACEROLA (UNII: XDD2WEC9L5)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ACETYL TETRAPEPTIDE-5 (UNII: Y1DFQ308G8)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    WHITE TEA (UNII: O0M3396E09)  
    ALLANTOIN (UNII: 344S277G0Z)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    ACAI (UNII: 46AM2VJ0AW)  
    GINKGO BILOBA ROOT (UNII: 1XUK686051)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    WATER (UNII: 059QF0KO0R)  
    CETEARETH-22 (UNII: 28VZG1E234)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ALLYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (LOW ALLYL METHACRYLATE) (UNII: PI80E777XB)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    Product Characteristics
    Colorwhite (white yellowish) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35192-033-16141.7 g in 1 TUBE; Type 0: Not a Combination Product04/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/30/2021
    Labeler - CA-Botana International (106276728)
    Establishment
    NameAddressID/FEIBusiness Operations
    CA-Botana International106276728manufacture(35192-033)