Label: SYS- octinoxate, titanium dioxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 June 18, 2014

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  • Active Ingredients

    Octinoxate 7.5%

    Titanium Dioxide 6.0%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and early skin aging caused by the sun.
  • Warnings

    For external use only

  • DO NOT USE

    Do not use on damaged or broken skin

  • WHEN USING

    When using this product keep out of eyes. If contact occures rinse with water to remove.

  • STOP USE

    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.
    • Reapply at least every 2 hours
    • Use water resistant sunscreen if swimming or sweating
    • Immediately after towel drying
    • At least every 2 hours
    • 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 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.
    • Children under 6 months ask a doctor
  • Inactive ingredients

    water, cyclopentasiloxane, glycerin, cetyl ethylhexanoate, tribehenin PEG-20 esters, caprylyl methicone, dimethicone, stearic acid, polyglyceryl-3 polydimethylsiloxyethyl dimethicone, polysorbate 80, aluminum hydroxide, squalane, isohexadecane, sodium acrylate/sodium acryloyldimehtyl taurate/acrylamide copolymer, hydroxyacetophenone, dimethicone/PEG-10/15 corosspolymer, cetyl alcohol, nylon-12, linoleic acid, palmitoyl tripeptide-5, 1,2-hexanediol, caprylyl glycol, dextrin, hydrolyzed hibiscus esculentus extract, sodium hyaluronate, xanthan gum, tocopherol, disodium EDTA, sodium hydroxide, vitis vinifera (grape) seed extract, glycine soja (Soybean) oil, fragrance, algae extract, glycine soja (soybean) seed extract, ergocalciferol, linolenic acid, camellia sinensis leaf extract, aloe barbadensis leaf extract, potassium sorbate, sodium benzoate, ascorbic acid

  • Other Information

    • protect this product from excessive heat and direct sun
  • Questions or comments?

    Call 800-542-4800

    Made in USA. Manufactured for and distributed by AdvoCare International L.P. Plano, TX 75074 www.advocare.com

  • Principal Display

    SYS

    supplement your skin

    day

    moisturizer

    with sunscreen

    broad specturm SPF 20

    with vitamins C, D, E and F

    and hibiscus and grape seed extracts

    carton image

  • INGREDIENTS AND APPEARANCE
    SYS 
    octinoxate, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68990-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 g  in 50 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    SQUALANE (UNII: GW89575KF9)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    4-HYDROXY ACETOPHENONE (UNII: G1L3HT4CMH)  
    NYLON-12 (UNII: 446U8J075B)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    ERGOCALCIFEROL (UNII: VS041H42XC)  
    LINOLENIC ACID (UNII: 0RBV727H71)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68990-001-0150 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/01/2014
    Labeler - AdvoCare International L.P. (799232707)
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