Otc - Active Ingredient
Active Ingredients
Titanium Dioxide........... 4.31%
Zinc Oxide....................19.27%
Protective Tinted Moisturizer Broad Spectrum Sunscreen Spf 30 Paste
FDA Label NDC 65278-104
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by June Jacobs Labs Llc for the product Protective Tinted Moisturizer Broad Spectrum Sunscreen Spf 30 (NDC 65278-104). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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 - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
- In case of contact with eyes, rinse with water
- If rash occurs, stop use and consult a doctor
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.
Dosage & Administration
Directions
- Use daily after cleanser or serum for protective moisture and younger-looking skin. Apply to face and neck liberally 15 minutes before sun exposure. Reapply at least every two hours
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early 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 sleeve shirts, pants, hats and sunglasses
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating
- Children under 6 months: Ask a doctor
Inactive Ingredient
Inactive Ingredients
Ethyl Macadamiate, Caprylic/Capric Triglyceride, Saccharomyces Ferment, Coco Caprylate/Caprate, Behenyl Behenate, Sorbitol/Sebacic Acid Copolymer Behenate, Polyhydroxystearic Acid, Octyldodecyl Erucate, Euphorbia Cerifera (Candelilla) Wax, Fragrance/Parfum, Lauroyl Lysine, Iron Oxides, Stearic Acid, Alumina, Glyceryl Caprylate, Butyrospermum Parkii (Shea) Butter, Persea Gratissima (Avocado) Oil , Argania Spinosa Kernel Oil, Tocopheryl Acetate, Polyglyceryl-6 Polyricinoleate, Dilinoleic Acid/Butanediol Copolymer, Tocopherol, Glyceryl Undecylenate, Malic Acid, Castor Oil/IPDI Copolymer, Glycerin, Lycium Barbarum Fruit Extract , Punica Granatum Extract, Vitis Vinifera (Grape) Seed Extract, Aspalathus Linearis Leaf Extract , Leuconostoc/Radish Root Ferment Filtrate, Camellia Sinensis Leaf Extract, Limonene, Linalool, Citral.
Other Safety Information
Other information
■ Protect this product from excessive heat and direct sun
Otc - Questions
Questions or comments?
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