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

  • 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 April 28, 2023

If you are a consumer or patient 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.
    • 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 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.
  • 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 not finalpart35209/01/2021
    Labeler - e.l.f. Cosmetics, Inc (093902816)