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 July 5, 2017

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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.
  • 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.
    • Use a water resistant sunscreen if swimming or sweating.
    • Reapply at least every 2 hours or after sweating.
    • Children under 6 months of age: Ask a doctor. (Not intended for use on children)
  • Other Ingredients

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

  • Skin Cancer/Skin Aging Alert & 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 value of 15 or higher and other sun protection measures including:

    • limit time in the sun, especially from 10 a.m.-2p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses

    This product has been shown to help prevent sun burn, not skin cancer or early skin aging.

  • Other Information

    Store at 15 - 25°C (59 - 77°F). Protect the product in this container from excessive heat and freezing conditions.

    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.

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    Pharmco Laboratories Inc. • Titusville, FL 32780

  • PRINCIPAL DISPLAY PANEL - 87 g Tube Label

    PHARMCO
    SKINCARE LABS

    Anti-Aging
    Day Protect
    SPF 22

    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:58400-006
    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 350 (UNII: 2Y53S6ATLU)  
    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:58400-006-0187 g in 1 TUBE; Type 0: Not a Combination Product06/01/2012
    2NDC:58400-006-023900 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35206/01/2012
    Labeler - Pharmco Laboratories Inc. (096270814)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmco Laboratories Inc.096270814MANUFACTURE(58400-006) , LABEL(58400-006) , PACK(58400-006) , ANALYSIS(58400-006)
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