FDA Label for Zinc Oxide

View Indications, Usage & Precautions

Zinc Oxide Product Label

The following document was submitted to the FDA by the labeler of this product Goodier Cosmetics Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



DAILY FACE
CREAM


SUNSCREEN
ZINC OXIDE
BROAD SPECTRUM SPF 20

PATENTED
NERIUM ALOE
EXTRACT
NAE-8®

Manufactured for:
Nerium SkinCare, Inc.
San Antonio, TX 78230


Otc - Active Ingredient



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


Indications & Usage



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



Warnings
For external use only


Otc - Do Not Use



Do not use • on damaged or broken skin


Otc - When Using



When using this product • keep out of eyes.
Rinse with water to remove.


Otc - Ask Doctor



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


Otc - Keep Out Of Reach Of Children



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


Instructions For Use



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 Safety Information



Other Information
• Storage: Transport and store in a cool, dry
area. Keep away from direct sunlight.
• 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 Ingredient



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 (NAE-8®), Hydrolyzed Egg Shell Membrane (Peptide Matrix - Collagen & Elastin),
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


Otc - Questions



Questions?
1-(866)-535-5888 M-F (9 am to 5 pm CST)


Package Label.Principal Display Panel



1floz Pure Daily Face Cream

1floz Advanced Daily Face Cream


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