Label: DAILY SPF 20 OLEANDER FACE CREAM- 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 October 19, 2021

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  • NeriumRX™ Daily Age-Defying Face Moisturizer

    NERIUM
    SKINCARE™

    NeriumRX™
    Daily Age-Defying
    Face Moisturizer

    Sunscreen - Zinc Oxide
    Broad Spectrum SPF20
    Medium Protection

    NAE-14™ Proprietary
    Nerium Extract

    30 ml/1 FL.OZ.

    Active Ingredient                          Purpose
    Zinc Oxide 12.5%............................Sunscreen

    Uses
    • Helps prevent sunburn
    • Higher SPF gives more sunburn protection
    • Provides moderate protection against 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

    Do not use • on damaged or broken skin

    For External Use only
    When using this product • keep out of eyes.
    Rinse with water to remove.

    Stop use and ask a doctor if • rash or irritation develops and lasts

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

    Directions
    • Apply generously before sun exposure and as needed
    • Children under 6 months of age: ask a doctor
    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.

    Other Information
    • Moderate sun protection product
    • Sun alert: limiting sun exposure, wearing protective clothing, and using sunscreens may
    reduce the risks of skin aging, skin cancer, and other harmful effects of the sun
    • Protect the product in this container from excessive heat and direct sun.

    Inactive Ingredients
    Water, C12-15 Alkyl Benzoate, Glycerin, Aloe Barbadenis Leaf Juice, Cetearyl Alcohol,
    Ceteth-20 Phosphate, Oleth-3 Phosphate, Isostearic Acid, Silica, Nerium Oleander Leaf
    Extract, Hydrolyzed Egg Shell Membrane, Caprylyl Glycol, Leuconostoc/Radish Root
    Ferment Filtrate, Superoxide Dismutase, Polygonum Aviculare Extract, Dimethicone,
    Cetearyl Glucoside, Niacinamide, Sodium Hyaluronate, Tetrahexyldecyl Ascorbate, Glyceryl
    Caprylate, Avena Sativa (Oat) Kernel Extract, Chamomilla Recutita (Matricaria) Flower Extract,
    Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopheryl Acetate, Dipotassium Glycyrrhizinate,
    Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Palmitoyl Tripeptide-5,
    Tetradecyl Aminobutyroylvalylaminobutyric Urea Trifluoroacetate, Glyceryl Stearate Citrate,
    Magnesium Chloride, Xanthan Gum, Disodium EDTA, Phenylpropanol, Dicetyl Phosphate,
    Polyhydroxystearic Acid, Potassium Sorbate, Fragrance, Mica, Titanium Dioxide, Pentylene
    Glycol, Phenoxyethanol, Sodium Benzoate, Tromethamine.

    Manufactured for:
    Nerium SkinCare, Inc.
    11467 Huebner Road, Ste 175
    San Antonio, TX 78230

  • Nerium Advanced Daily Face Cream

    NERIUM
    SKINCARE, INC.

    ADVANCED

    SUNSCREEN
    ZINC OXIDE
    BROAD SPECTRUM SPF 20

    DAILY FACE CREAM

    PATENTED
    NERIUM OLEANDER EXTRACT

    30 mL/1 fl.oz.

    Active Ingredient                          Purpose
    Zinc Oxide 12.5%............................Sunscreen

    Uses
    • Helps prevent sunburn
    • Higher SPF gives more sunburn protection
    • Provides moderate protection against 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

    Do not use • on damaged or broken skin

    For External Use only
    When using this product • keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if • rash or irritation develops and lasts

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

    Directions
    • Apply generously before sun exposure and as needed
    • Children under 6 months of age: ask a doctor
    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.

    Other Information
    • Moderate sun protection product
    • Sun alert: limiting sun exposure, wearing protective clothing, and using sunscreens may
    reduce the risks of skin aging, skin cancer, and other harmful effects of the sun
    • Protect the product in this container from
    excessive heat and direct sun.

    Inactive Ingredients
    Water, C12-15 Alkyl Benzoate, Glycerin, Aloe Barbadenis Leaf Juice, Cetearyl Alcohol,
    Ceteth-20 Phosphate, Oleth-3 Phosphate, Isostearic Acid, Silica, Nerium Oleander Leaf
    Extract, Hydrolyzed Egg Shell Membrane, Caprylyl Glycol, Leuconostoc/Radish Root
    Ferment Filtrate, Superoxide Dismutase, Polygonum Aviculare Extract, Dimethicone,
    Cetearyl Glucoside, Niacinamide, Sodium Hyaluronate, Tetrahexyldecyl Ascorbate, Glyceryl
    Caprylate, Avena Sativa (Oat) Kernel Extract, Chamomilla Recutita (Matricaria) Flower Extract,
    Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopheryl Acetate, Dipotassium Glycyrrhizinate,
    Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Palmitoyl Tripeptide-5,
    Tetradecyl Aminobutyroylvalylaminobutyric Urea Trifluoroacetate, Glyceryl Stearate Citrate,
    Magnesium Chloride, Xanthan Gum, Disodium EDTA, Phenylpropanol, Dicetyl Phosphate,
    Polyhydroxystearic Acid, Potassium Sorbate, Fragrance, Mica, Titanium Dioxide, Pentylene
    Glycol, Phenoxyethanol, Sodium Benzoate, Tromethamine.

    Manufactured for:
    Nerium SkinCare, Inc.
    11467 Huebner Road, Ste 175
    San Antonio, TX 78230

  • PRINCIPAL DISPLAY PANEL

    Nerium RX Label 30mL

    Nerium RX Label 30mL

    Nerium Advanced Label 30mL

    Nerium Advanced Label 30mL

  • INGREDIENTS AND APPEARANCE
    DAILY SPF 20 OLEANDER FACE CREAM 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10477-0063
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10477-0063-11 in 1 CARTON11/17/2017
    130 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/17/2017
    Labeler - Goodier Cosmetics (007317209)
    Registrant - Goodier Cosmetics (007317209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Goodier Cosmetics007317209manufacture(10477-0063)