Active Ingredients
Active Ingredients:
Titanium Dioxide 4.7%
Zinc Oxide 9.5%
Natural Mineral Sunscreen Lotion
FDA Label NDC 67676-009
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sarati International, Inc. for the product Natural Mineral Sunscreen (NDC 67676-009). 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 & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Sunscreen
Indications & Usage
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
Warnings:
- For external use only
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If product is swallowed, get medical help or contact a Poison Control Center right away
Dosage & Administration
Directions:
- Apply liberally and evenly 15 minutes before sun exposure. Apply to all skin exposed to the sun.
- Reapply
- after 40 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- 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.
- Children under 6 months of age: Ask a doctor.
Inactive Ingredient
Alumina, Behentrimonium Methosulfate, C12-15 Alkyl Benzoate, Caprylic/Capric Triglycerides, Cetearyl Alcohol, Coffea Arabica (Coffee) Fruit Extract, Deionized Water, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Disodium EDTA, Disteardimonium Hectorite, Ethylhexylglycerin, Ferulic Acid, Glycerin, Hydrogenated Ethylhexyl Olivate, Hydrogenated Olive Oil Unsaponifiables, Isohexdecane, Niacinamide, PEG-30 Dipolyhydroxystearate, Phenoxyethanol, Polyhydroxystearic Acid, Propanediol, Propylene Carbonate, Raspberry Ketone, Sodium Chloride, Stearic Acid, Triethoxycaprylylsilane
Other Safety Information
Other information: Protect the product in this container from excessive heat and direct sun.
Recent Major Changes
Updated directions as required for Broad Spectrum and Water Resistant Testing
Updated label and principal display panel.
Otc - Do Not Use
Do not use
- on danaged or broken skin
Otc - When Using
When using this product,
- keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor
- if rash occurs.
Package Label.Principal Display Panel
STELLAR
SUNSCREEN
Broad Spectrum SPF 30
Water Resistant
(40 minutes)
30
Net Wt. 3.4 fl. oz.
* Please review the disclaimer below.
