Label: NATRIENCE BROAD SPECTRUM SPF 30- skin shield cream

  • NDC Code(s): 84352-402-01
  • Packager: Sisel International, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 28, 2024

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Zinc Oxide 20%........................ Sunscreen

  • OTC - Purpose

    Sunscreen

  • Indications and Usage

    • Apply liberally 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a 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 the sun, especially from 10 a.m. - 2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses
    • For children under 6 months of age: Ask a doctor

  • Dosage and Administration

    Cream

  • BOXED WARNING (What is this?)

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

  • OTC - Keep out of reach of Children

    Keep out of reach of children

  • Inactive Ingredients

    Water (Aqua), Ethylhexyl Olivate, C9-12 Alkane, Hydroxyethyl Dimethicone Laurate, Propanediol, Calcium Sodium Borosilicate, Pentylene Glycol, Polymethylsilsesquioxane, Butylene Glycol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Cocoglycerides, Jojoba Esters, Dimethicone, Betaine, Sucrose, Spirulina Maxima Extract, Fructooligosaccharides, Beta Vulgaris (Beet) Root Extract,
    Hydrolyzed Rhodophyceae Extract, Helianthus Annuus (Sunflower) Seed Oil, Phaeodactylum Tricornutum Extract, Dipotassium Glycyrrhizate, Persea Gratissima (Avocado) Oil, Squalane, Caprylic/Capric Triglyceride, Tocopherol, Lecithin, Hydroxyacetophenone, Disteardimonium Hectorite, Polyhydroxystearic Acid, Trihydroxystearin, Triethyl Citrate, Caprylyl Glycol, Tetrasodium Glutamate Diacetate, Sodium Dehydroacetate, Hydrogenated Vegetable Oil, Caprylhydroxamic Acid, Sodium Chloride, Sodium Citrate, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Fragrance (Natural).

  • Indications and Usage

    Apply a generous amount in an even layer to face and neck. Use daily as the last step in your skin care routine, before makeup, and at least 15 minutes before sun exposure.

    Tube Directions

  • Warnings

    For external use only. Avoid contact with eyes. Do not apply to damaged or irritated skin. If irritation or redness occurs, discontinue use.

    Tube

  • Principal Display

    DRUG FACTS
    Active Ingredients Purpose
    Zinc Oxide 20%........................ 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
    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 product is
    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 a 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 the sun, especially
    from 10 a.m. - 2 p.m.
    • Wear long-sleeved shirts, pants,
    hats, and sunglasses
    • For children under 6 months of age:
    Ask a doctor
    Inactive Ingredients:
    Water (Aqua), Ethylhexyl Olivate, C9-12
    Alkane, Hydroxyethyl Dimethicone
    Laurate, Propanediol, Calcium Sodium
    Borosilicate, Pentylene Glycol,
    Polymethylsilsesquioxane, Butylene Glycol,
    Butyloctyl Salicylate, C12-15 Alkyl
    Benzoate, Cocoglycerides, Jojoba Esters,
    Dimethicone, Betaine, Sucrose, Spirulina
    Maxima Extract, Fructooligosaccharides,
    Beta Vulgaris (Beet) Root Extract,
    Hydrolyzed Rhodophyceae Extract,
    Helianthus Annuus (Sunflower) Seed Oil,
    Phaeodactylum Tricornutum Extract,
    Dipotassium Glycyrrhizate, Persea
    Gratissima (Avocado) Oil, Squalane,
    Caprylic/Capric Triglyceride, Tocopherol,
    Lecithin, Hydroxyacetophenone,
    Disteardimonium Hectorite,
    Polyhydroxystearic Acid,
    Trihydroxystearin, Triethyl Citrate, Caprylyl
    Glycol, Tetrasodium Glutamate Diacetate,
    Sodium Dehydroacetate, Hydrogenated
    Vegetable Oil, Caprylhydroxamic Acid,
    Sodium Chloride, Sodium Citrate, Iron
    Oxides (CI 77492), Iron Oxides (CI 77491),
    Fragrance (Natural).
    Other Information
    Protect the product in this container from
    excessive heat and direct sun.

    Principal Display

  • INGREDIENTS AND APPEARANCE
    NATRIENCE  BROAD SPECTRUM SPF 30
    skin shield cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84352-402
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYL OLIVATE (UNII: HTC7G3S2PV)  
    COCO-GLYCERIDES (UNII: ISE9I7DNUG)  
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    C9-12 ALKANE (UNII: 7J5R5W72QM)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    PHAEODACTYLUM TRICORNUTUM (UNII: Y5W63E7HLV)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES (UNII: N2UDM48ZD6)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    SQUALANE (UNII: GW89575KF9)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    BOROSILICATE GLASS (UNII: BOJ6T9AR90)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    BETAINE (UNII: 3SCV180C9W)  
    SUCROSE (UNII: C151H8M554)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SPIRULINA MAXIMA (UNII: 9K7IG15M0Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84352-402-011 in 1 BOX06/15/2024
    120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/15/2024
    Labeler - Sisel International, LLC (794763198)