Ultra Light Invisible Spf 40 Sunscreen Gel
FDA Label NDC 84190-001
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rk Shea Llc for the product Ultra Light Invisible Spf 40 Sunscreen (NDC 84190-001). 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 ingredients purpose avobenzone 3% sunscreen homosalate 8% sunscreen octisalate 5% sunscreen octocrylene 4.0% sunscreen, uses, warnings for external use only., keep out of reach of children., directions, other information ·, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
· helps prevent sunburn
Warnings For External Use Only.
Do not useon damaged or broken skin.
When using this product· keep out of eyes . Rinse with water to
remove.
Stop use and ask doctor if rash occurs.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center immediately.
Directions
Apply evenly by hand 15 minutes before sun exposure · 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 of 15 or higher and other sun protection measures including · limit time in the sun, especially
from 10 a.m. - 2 p.m. · wear a long-sleeved shirts, pants, hats, and sunglasses. · children under 6 months: Ask a doctor.
Other Information ·
protect this product from excessive heat and direct sun · may stain fabrics.
Inactive Ingredients
Boswellia Serrata Resin Extract
Butyrospermum Parkii (Shea) Butter
Caprylic/Capric Triglyceride
Caprylyl Glycol
Cyclopentasiloxane
Cyclotetrasiloxane
Cyclohexasiloxane
Diatomaceous Earth
Dicaprylyl Carbonate
Dimethicone
Dimethicone Crosspolymer
Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer
Hyaluronic acid, sodium salt
Isododecane
Lecithin
Lithothamnion Calcareum Extract
Mannitol
Meadowfoam Estolide
Microcrystaline Cellulose
Neopentyl Glycol Diheptanoate
Polyester-7
Polymethylsilsesquioxane
Silica
Simmondsia Chinensis (Jojoba) Seed Oil
Tetrahexyldecyl Ascorbate
Tocopheryl Acetate
Zinc Sulfate
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