Boxed Warning
Drug Facts
Josie Maran Argan Daily Moisturizer Spf47 Lotion
FDA Label NDC 51514-0332
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Autumn Harp, Inc. for the product Josie Maran Argan Daily Moisturizer Spf47 (NDC 51514-0332). 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 boxed warning, active ingredients, purpose, uses, warnings, directions:, otc - when using, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Zinc Oxide 6.4%**
Titanium Dioxide 5.1%**
Purpose
Sunscreen
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.
Stop use and ask a doctor if rash occurs.
When using this product
· keep out of eyes
· rinse with water to remove
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
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months: Ask a doctor
Otc - When Using
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 10am - 2pm.
• Wear long-sleeve shirts, pants, hats, and sunglasses
Inactive Ingredients:
Aqua (Water)**, Ethylhexyl Palmitate, Caprylic/Capric
Triglyceride**, Aloe Barbadensis Leaf Juice*, Polyglyceryl-6
Polyricinoleate**, Cyclopentasiloxane, Polysilicone-11,
Argania Spinosa (Argan) Kernel Oil**, Glycerin**, Cera Alba
(Beeswax)*, Coco-Caprylate/Caprate, Phenoxyethanol,
Polyhydroxystearic Acid, Methicone, Alumina, Tocopheryl
Acetate, Sodium Chloride**, Triethoxycaprylylsilane,
Polyglyceryl-10 Laurate, Parfum (Fragrance)**, Bisabolol,
Dimethicone, Simmondsia Chinensis (Jojoba) Seed Oil*,
Laureth-12, Ethylhexylglycerin, Camellia Sinensis (Green
Tea) Leaf Extract*, Citric Acid**, Potassium Sorbate**,
Sodium Benzoate**.
*ORGANIC **NATURAL
Other Information:
· Protect this product from excessive heat and direct sun.
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