Label: GUARDIAN ANGEL SUPER PEPTIDE SUNSCREEN MILK SPF-50- zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 8, 2023

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  • ACTIVE INGREDIENT

    Zinc Oxide 12%

  • PURPOSE

    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
  • KEEP OUT OF REACH OF CHILDREN

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

  • 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 OCCURS

  • DIRECTIONS

    • shake or knead before each use
    • apply generously and evenly 15 minutes before sun exposure
    • use a water-resistant sunscreen if swimming or sweating
    • reapply at least every two hours

    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use asunscreen 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-sleeve shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor
  • INACTIVE INGREDIENTS

    Water (Aqua), C12-15 Alkyl Benzoate, Caprylic/Capric Triglycerides, Jojoba Esters, Propanediol, Tridecyl Salicylate, Methylheptyl Isostearate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Niacinamide, Methylpropanediol, Nylon-12 (Plant Derived), Glycerin, Silica, Palmitoyl Pentapeptide-4, Terminalia Bellerica Fruit, Terminalia Chebula Fruit Extract, Terminalia Ferdinandiana Fruit Extract, Phyllanthus Emblica Fruit Extract, Pleiogynium Timoriense Fruit Extract, Podocarpus Elatus Fruit Extract, Ubiquinone, Helianthus Annuus (Sunflower) Extract, Oryza Sativa (Rice) Bran Extract, Propanediol, Allantoin, Bisabolol, Caprylyl Glycol, Lecithin, Caprylyl Glycol, Coco-Caprylate, Phenylpropanol, Sodium Chloride, Sodium Hydroxide, Tetrasodium Glutamate, Diacetate, Tocopherol, Tocopheryl Acetate, Polyglyceryl-2 Dipolyhydroxystearate

  • OTHER INFORMATION

    • Protect this product from excessive heat and direct sun.
  • QUESTIONS OR COMMENTS

    • 1-855-859-1600 (9am – 5pm ET)
  • PRINCIPAL DISPLAY PANEL

    0-UC_GuardianAngel_01 - IP220106D

  • INGREDIENTS AND APPEARANCE
    GUARDIAN ANGEL SUPER PEPTIDE SUNSCREEN MILK  SPF-50
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73054-126
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION12 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PHYLLANTHUS EMBLICA FRUIT JUICE (UNII: K8SGU56WPQ)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    NYLON-12 (UNII: 446U8J075B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)  
    TERMINALIA BELLIRICA FRUIT (UNII: DYY1OQ3CMP)  
    KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    TERMINALIA CHEBULA FRUIT (UNII: S8R4V700NK)  
    RICE BRAN (UNII: R60QEP13IC)  
    METHYLHEPTYL ISOSTEARATE (UNII: 981F40Q9FF)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    PODOCARPUS ELATUS FRUIT (UNII: R4N1M6CZCY)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PLEIOGYNIUM TIMORIENSE FRUIT (UNII: AF3VFG6MLV)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73054-126-111 in 1 BOX10/17/2021
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/17/2021
    Labeler - SOLARA SUNCARE, INC. (040998319)
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