Label: ANTI-AGING DAY PROTECT SPF 22- octinoxate, octisalate, and avobenzone 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 September 4, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientPurpose
    Avobenzone 2%Sunscreen
    Octinoxate 7.5%Sunscreen
    Octisalate 5%Sunscreen
  • Uses

    • Helps prevent sunburn.
    • Higher SPF gives more sunburn protection.
    • Provides moderate protection for skin that sunburns easily
  • 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 or irritation develops and lasts

    • Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.
  • Directions

    • After cleansing apply evenly to face and neck every morning, at least 15 minutes before sun exposure.
    • Reapply as needed or after sweating or perspiring.
    • Children under 6 months of age: Ask a doctor. (Not intended for use on children)
  • Other Ingredients

    Acetyl Hexapeptide-3, Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Camellia Sinensis (Green Tea) Extract, Capric/Caprylic Triglycerides, Caprylyl Glycol, Carbomer, Cetyl Alcohol, Diaminopropionoyl Tripeptide-33, Dimethicone, Disodium EDTA, Fragrance, Glyceryl Stearate, Hexylene Glycol, Octyldodecanol, Squalane, PEG 100 Stearate, Phenoxyethanol, Polyacrylate-13, Polyisobutene, Polysorbate 20, Polysorbate 60, Propylene Glycol, Sodium Hydroxide, Stearyl Alcohol, Titanium Dioxide, Tocopheryl Acetate, Ubiquinone 50, Water.

  • Other Information

    Moderate sun protection product.

    SUN ALERT

    Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

    Protect the product in this container from excessive heat and direct sun.

  • PRINCIPAL DISPLAY PANEL - 87 g Tube Label

    SB

    +Swiss Botany™

    Anti-Aging
    Day Protect SPF22

    Net wt. 3 oz. (87 g)

    Principal Display Panel - 87 g Tube Label
  • INGREDIENTS AND APPEARANCE
    ANTI-AGING DAY PROTECT SPF 22 
    octinoxate, octisalate, and avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70048-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 g
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 g
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Acetyl Hexapeptide-8 (UNII: L4EL31FWIL)  
    Aloe (UNII: V5VD430YW9)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Tricaprin (UNII: O1PB8EU98M)  
    Tricaprylin (UNII: 6P92858988)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Edetate Sodium (UNII: MP1J8420LU)  
    Polyisobutylene (1000 MW) (UNII: 5XB3A63Y52)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Hexylene Glycol (UNII: KEH0A3F75J)  
    Octyldodecanol (UNII: 461N1O614Y)  
    Squalane (UNII: GW89575KF9)  
    Peg-100 Stearate (UNII: YD01N1999R)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70048-001-0187 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35206/01/2012
    Labeler - Swiss Botany (079860471)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmco Laboratories Inc.096270814MANUFACTURE(70048-001) , LABEL(70048-001) , PACK(70048-001) , ANALYSIS(70048-001)
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