Label: BABY MINERAL SUNSCREEN SPF55- zinc oxide 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 28, 2023

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  • Drug Facts

  • Active Ingredients

    Zinc Oxide 20.0%

  • 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
  • Warnings

    For external use only

    Do not use on

    broken or damaged skin

    When using this product

    Keep out of eyes. Rinse with water to remove

    Stop use and ask a doctor if

    rash occurs

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • Shake well before use
    • Apply liberally and spread evenly by hand 15 minutes before sun exposure
    • Reapply after 80 minutes of swimming or sweating, immediately after towel use, at least every 2 hours
    • For children under 6 months of age, ask a doctor
    • Sun Protection Measures Spending time in the sun can increase your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
      • Limiting time in the sun, especially from 10a.m. - 2p.m.
      • Wearing long-sleeved shirts, pants, hats and sunglasses
  • Other Information

    • Protect this product from excessive heat and direct sun
    • Avoid long-term exposure storage above 40°C (104°F)
    • May stain some fabrics
  • Inactive Ingredients

    Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Bisabolol*, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter*, Calendula Officinalis Flower Extract*, Camellia Sinensis Leaf Extract*, Caprylhydroxamic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract*, Citric Acid, Citrus Aurantium Dulcis (Orange) Peel Oil, Coco Glucoside, Cocos Nucifera (Coconut) Oil*, Cucumis Sativus (Cucumber) Fruit Extract*, Diheptyl Succinate, Glycerin, Methyl Dihydroabietate, Microcrystalline Cellulose, Persea Gratissima (Avocado) Fruit Extract*, Polyhydroxystearic Acid, Prunus Armeniaca (Apricot) Kernel Oil*, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Triethyl Citrate, Vanilla Planifolia Fruit Extract, Water (Aqua) *Organic

  • PRINCIPAL DISPLAY PANEL

    HelloBello_sunscreen_dieline_109C_March2022_AO

  • INGREDIENTS AND APPEARANCE
    BABY MINERAL SUNSCREEN SPF55 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73418-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LEVOMENOL (UNII: 24WE03BX2T)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
    POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    VANILLA BEAN (UNII: Q74T35078H)  
    WATER (UNII: 059QF0KO0R)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CUCUMBER (UNII: YY7C30VXJT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
    AVOCADO (UNII: SDS87L369F)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73418-100-0385.05 g in 1 TUBE; Type 0: Not a Combination Product07/28/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02007/28/2023
    Labeler - Hello Bello (081135707)
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