Active Ingredients
Zinc Oxide 20%........................ Sunscreen
Natrience Cream
FDA Label NDC 84352-402
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sisel International, Llc for the product Natrience (NDC 84352-402). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, otc - purpose, indications and usage, dosage and administration, boxed warnings, otc - keep out of reach of children, inactive ingredients, warnings, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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.
Dosage And Administration
Cream
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).
Warnings
For external use only. Avoid contact with eyes. Do not apply to damaged or irritated skin. If irritation or redness occurs, discontinue use.
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.
* Please review the disclaimer below.
