Label: DAILY FACIAL MOISTURIZER SPF 35- octinoxate and avobenzone lotion

  • NDC Code(s): 58400-007-01, 58400-007-02
  • Packager: Pharmco Laboratories Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 10, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient:Purpose
    Avobenzone 2.5%Sunscreen
    Octinoxate 4%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, Carthamus Tinctorius (Safflower) Oleosomes, C12-15 Alkyl Benzoate, C13-14 Isoparrafin, Laureth 7, Polyacrylamide, Benzyl Alcohol, Fragrance, Sodium Hydroxide, Methylisothiazolinone, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Citric Acid

  • 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.-2 p.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 15-30°C (59-86°F). Protect the product in this container from excessive heat and or freezing conditions.

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    Pharmco Laboratories Inc. • Titusville, FL 32780
    www.pharmcolabs.com • 1.800.635.0712 • Reorder CPL16-3

  • PRINCIPAL DISPLAY PANEL - 87 g Tube Label

    PHARMCO
    SKINCARE LABS

    Daily Facial
    Moisturizer

    Broad Spectrum SPF 30+

    Net wt. 3 oz. (87 g)

    PRINCIPAL DISPLAY PANEL - 87 g Tube Label
  • INGREDIENTS AND APPEARANCE
    DAILY FACIAL MOISTURIZER SPF 35 
    octinoxate and avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58400-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate40 mg  in 1 g
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Aloe (UNII: V5VD430YW9)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Carthamus Tinctorius Seed Oleosomes (UNII: 9S60Q72309)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    C13-14 Isoparaffin (UNII: E4F12ROE70)  
    Laureth-7 (UNII: Z95S6G8201)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58400-007-0187 g in 1 TUBE; Type 0: Not a Combination Product06/01/2012
    2NDC:58400-007-023900 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 DrugM02006/01/2012
    Labeler - Pharmco Laboratories Inc. (096270814)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmco Laboratories Inc.096270814MANUFACTURE(58400-007) , LABEL(58400-007) , PACK(58400-007) , ANALYSIS(58400-007)
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