Label: REPLENIX TINTED SUNSCREEN SPF 50- zinc oxide and octinoxate 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 February 22, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientPurpose
    Zinc Oxide 14.5%Sunscreen
    Octinoxate 7.5%Sunscreen
  • Uses

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

    For external use only.

    When using this product keep out of eyes, rinse with water to remove.

    Stop use if signs of irritation or rash appear. If irritation or rash persists consult a doctor.

    Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

    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 sunscreen measures including:

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

    • Apply liberally to face and neck and spread evenly 15 minutes before sun exposure
    • Re-apply after swimming, excessive perspiring, or anytime after towel drying
    • Use a water resistant sunscreen if swimming or sweating
    • Use on children under 6 months of age: consult a doctor.
  • Inactive ingredients

    Purified Water, Niacinamide, Oleth-3 Phosphate, Neopentyl Glycol Diheptanoate, Polyisobutene, Octyldodecyl Neopentanoate, Butylene Glycol, Sodium Hyaluronate, Tocopheryl Acetate, Caffeine, Dimethicone, Panthenol, Sucrose, Jojoba Esters, Lactic Acid, Glycerin, Ethylhexyl Stearate, Triethoxycaprylylsilane, Xanthan Gum, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Iron Oxides, PEG-7 Trimethylolpropane Coconut Ether, Hydroxyethyl Acrylate/Sodium Acryloydimethyl Taurate Copolymer, Phenoxyethanol, Disodium EDTA.

  • PRINCIPAL DISPLAY PANEL - 63 g Bottle Label

    REPLENiX®
    SUNSCREEN

    ESSENTIAL
    OIL FREE TINTED
    SPF 50

    14.5% Micronized Zinc Oxide
    Multi-tasking tinted application
    Sensitive skin friendly

    BROAD SPECTRUM UVA/UVB SPF 50

    Net wt. 2.22 oz. (63 g)

    TOPIX PHARMACEUTICALS, INC. N. AMITYVILLE, NY 11701

    PRINCIPAL DISPLAY PANEL - 63 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    REPLENIX TINTED SUNSCREEN   SPF 50
    zinc oxide and octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE145 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CAFFEINE (UNII: 3G6A5W338E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    SUCROSE (UNII: C151H8M554)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    LACTIC ACID, DL- (UNII: 3B8D35Y7S4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    FERROUS OXIDE (UNII: G7036X8B5H)  
    PEG-7 TRIMETHYLOLPROPANE COCONUT ETHER (UNII: MVJ3AD73GG)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51326-201-0163 g in 1 BOTTLE; Type 0: Not a Combination Product04/22/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/22/2022
    Labeler - Topiderm, Inc. (049121643)
    Registrant - Topiderm, Inc. (049121643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topiderm, Inc.049121643MANUFACTURE(51326-201)
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