Label: WELL PEOPLE BIO TINT SPF 30 SUNSCREEN 5N- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 6, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts

  • Active ingredient

    Zinc Oxide 20%

    Purpose

    Sunscreen

  • Use

    • 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.
  • Warning

    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.

    Keep out of reach of children.

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

  • Directions

    • Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours.
    • Use water resistant sunscreen if swimming or sweating.
    • 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 sun, especially from 10 a.m.-2 p.m., wear long-sleeved shirts, pants, hats and sunglasses. Children under 6 months of age: ask a doctor. Sun Protection Measures:
  • Other Information

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive Ingredients

    Water (Aqua), Coco-Caprylate/Caprate, Polyglyceryl-3 Polyricinoleate, Glycerin, Triethylhexanoin, Butyloctyl Salicylate, Butylene Glycol Dicaprylate/Dicaprate, Caprylic/Capric Triglyceride, Polyglyceryl-4 Isostearate, Magnesium Sulfate, Disteardimonium Hectorite, Shea Butter Ethyl Esters, Polyhydoxystearic Acid, Lecithin, Isostearic Acid, Gluconolactone, Cocos Nucifera (Coconut) Oil/Cocos Nucifera Oil*, Tocopherol, Helianthus Annuus (Sunflower) Seed Oil/ Helianthus Annuus Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil/ Simmondsia Chinensis Seed Oil*, Rubus Idaeus (Raspberry) Seed Oil/ Rubus Idaeus Seed Oil, Rosa Rubiginosa Seed Oil, Hippophase Rhamnoides (Sea Buckthorn) Oil/Hippophae Rhamnoides Oil, Crambe Abyssinica Seed Oil, Brassica Oleracea Italica (Broccoli) Seed Oil/ Brasica Oleracea Italica Oil, Aloe Barbadensis (Aloe) Leaf Juice/Aloe Barbadensis Leaf Juice, Maltodextrin, Potassium Sorbate, Glyceryl Caprylate, Sodium Benzoate, Isopropyl Titanium Triisostearate, Glyceryl Undecylenate, Calcium Gluconate, Phytic Acid MAY CONTAIN: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499) *Organic Ingredients

  • Questions or comments?

    1-888-315-9814

  • Package Labeling:

    Label6

  • INGREDIENTS AND APPEARANCE
    WELL PEOPLE BIO TINT SPF 30 SUNSCREEN 5N 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76354-481
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    CALCIUM GLUCONATE (UNII: SQE6VB453K)  
    FYTIC ACID (UNII: 7IGF0S7R8I)  
    WATER (UNII: 059QF0KO0R)  
    COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    JOJOBA OIL (UNII: 724GKU717M)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    ROSA RUBIGINOSA SEED OIL (UNII: 8M1P49MWAP)  
    CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)  
    BROCCOLI SEED OIL (UNII: SY01LVD4G4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76354-481-011 in 1 BOX09/01/2021
    135.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02009/01/2021
    Labeler - e.l.f. Cosmetics, Inc (093902816)