Active Ingredient
Zinc Oxide 12%
Sjolie Tanning Spf 30 Sunscreen Cream
FDA Label NDC 85947-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sjolie, Inc. for the product Sjolie Tanning Spf 30 Sunscreen (NDC 85947-001). 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 ingredient, purpose, uses, warnings, keep out of reach of children, directions, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Uses
Helps prevent sunburn. If used as directed with other sun protection measures (see directions), it 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 a rash occurs.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Shake before use.
Apply generously and evenly to the face and body before sun exposure.
Reapply:
after 80 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 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 10 a.m. - 2 p.m.
wear long-sleeved shirts, pants, hats, and sunglasses
children under 6 months of age: Ask a doctor.
Inactive Ingredients
Aleurites Moluccana (Kukui) Seed Oil, Aloe Barbadensis, Argania Spinosa Kernel Oil, Butyrospermum Parkii (shea) Butter, Camellia Sinensis (Green Tea) Leaf Extract, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) Extract, Deionized Water Dimethicone, Disodium EDTA, Ethyl Macadamiate, Ethylhexylglycerin, Fragrance, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Isosorbide Dicaprylate, Magnesium Aluminum Silicate, Phenethyl Benzoate, Phenoxyethanol, Poly C10-30 Alkyl Acrylate, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Polysorbate-80, Propanediol, Salvia Officinalis (Sage) Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Steareth-2, Steareth-21, Tapioca Starch, Tocopheryl Acetate (Vitamin E), Trimethoxyben-zylidene Pentanedione, Xanthan Gum
Other Information
Protect the product in this container from excessive heat and direct sun.
Questions Or Comments
Call 888-495-6064
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