Label: SUNSCREEN KARINA SKIN CARE SPF 15- octinoxate, emulsion

  • NDC Code(s): 35192-045-16
  • Packager: CA-Botana International
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 13, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active Ingredient

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

    Acrylates C10-30 Alkyl Acrylate Crosspolymer, Alanine, Allantoin, Aloe Barbadensis, Alpha Acetyl Tetrapeptide -5, Arginine, Camellia Sinensis (White tea) extract, Cetearyl Alcohol, Ceteary Isononanoate, Ceteareh-20, Cetyl Alcohol, Chamomillla recutita (Chamomile) extract, Coco-Caprylate/Caprate, Emulsifying Wax, Euterpe oleracea(Acai) Fruit extract, Ethtlhexylglycerin, Ethylhexyl Palmitate, Ginkgo Biloba leaf extract, Glycerin, Glycine, Juniperus Oxycedrus (Juniper berry ) extract, Malpighia glabra(Acerola) Fruit extract, Olea Europaea (Olive) Leaf extract, OXI CA (Rosmarinus officinalis leaf extract CO2 & Ascorbyl Palmitate & Caprylic/Capric/Tryglyceride & Ascorbic Acid, & Tocopherol & Citric Acid), Panthenol, Pentylene Glycol, Phenoxyethanol, Phosphatidylcholine, Potassium Sorbate, Prunus amygdalus dulcis (Sweet almond) oil, Proline, Propanediol, Simmondsia chinensis (Jojoba) Seed oil, Tetrasodium EDTA, Triethanolamine, Tocopheryl Acetate, Water (Aqua), Xanthan Gum

  • 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

  • Karina SPF 15

    Karina SpF 15. JPG (002).jpg

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN KARINA SKIN CARE SPF 15 
    octinoxate, emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35192-045
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 141.7 g
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    WATER (UNII: 059QF0KO0R)  
    CETEARETH-22 (UNII: 28VZG1E234)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    ALANINE (UNII: OF5P57N2ZX)  
    JUNIPER BERRY (UNII: O84B5194RL)  
    ACETYL TETRAPEPTIDE-5 (UNII: Y1DFQ308G8)  
    ARGININE (UNII: 94ZLA3W45F)  
    SOYBEAN PHOSPHATIDYLCHOLINE (UNII: 1T6N4D9YV6)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    ACEROLA (UNII: XDD2WEC9L5)  
    ROSEMARY (UNII: IJ67X351P9)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    WHITE TEA (UNII: O0M3396E09)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ACAI (UNII: 46AM2VJ0AW)  
    GLYCINE (UNII: TE7660XO1C)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)  
    MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02)  
    POLAWAX POLYSORBATE (UNII: Q504PL8E0V)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALLANTOIN (UNII: 344S277G0Z)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    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)  
    Product Characteristics
    Colorwhite (white yellowish) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35192-045-16141.7 g in 1 TUBE; Type 0: Not a Combination Product01/24/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/24/2022
    Labeler - CA-Botana International (106276728)
    Establishment
    NameAddressID/FEIBusiness Operations
    CA-Botana International106276728manufacture(35192-045)