Active Ingredient
Active Ingredient
Zinc Oxide (non-nano)
Sp-fb0d-l0tnbarrierprotectionmineralsunscreen Lotion
FDA Label NDC 87623-0002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Epic Etailers, Llc (dba: Beauty By Earth) for the product Sp-fb0d-l0tnbarrierprotectionmineralsunscreen (NDC 87623-0002). 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, directions, inactive ingredients, other information, otc - questions section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Active Ingredients Purpose
Zinc Oxide (non-nano) 15%.....Sunscreen
Uses
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
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
Directions
Apply generously 15 minutes before sun exposure
Reapply
After 40 minutes of swimming or sweating
Immediately after towel drying
At least every 2 hours
Children under 6 months: Ask a doctor
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 10:00 a.m. – 2 p.m.
Wear long-sleeved shirts, pants, hats, and sunglasses
Inactive Ingredients
Inactive Ingredients
Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, *Ricinus Communis (Castor) Seed Oil, Hydrogenated Castor Oil, Isodecyl Neopentanoate, Maranta Arundinacea Root (Arrowroot) Extract, Diisopropyl Sebacate, Lauryl Lactate, *Argania Spinosa (Argan) Kernel Oil, *Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Sunflower Derived), Heptyl Undecylenate, Squalane, Persea Gratissima (Avocado) Oil, *Butyrospermum Parkii (Shea) Butter, Aroma (Naturally Derived), Polyhydroxystearic Acid, Bentonite, Glyceryl Undecylenate
*Certified Organic Ingredients
Other Information
Other Information Protect this product from excessive heat and direct sun.
Otc - Questions Section
Questions? Call (469) 777-6501 or email [email protected]
Dosage & Administration
Directions
apply liberally and evenly 15 minutes before sun exposure
apply to all skin exposed to the sun
reapply:
after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
children under 6 months of age: ask a doctor
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
Indications & Usage
Indications & Usage
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
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.
* Please review the disclaimer below.
