Otc - Active Ingredient
Zinc Oxide 12.5% Sunscreen
Pure Sol Spf 50 Daily Moisturizer Liquid
FDA Label NDC 84090-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Brand 2022b Llc for the product Pure Sol Spf 50 Daily Moisturizer (NDC 84090-001). 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 otc - active ingredient, otc - purpose, warnings, otc - keep out of reach of children, indications & usage, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
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
Flammable: Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120F. Do not use in the presence of a flame or spark or while smoking.
Do not use on damaged or broken skin
When using this product, keep away from face to avoid breathing it. Keep out of eyes
Rinse with water to remove.
Otc - 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
Indications & Usage
Stop use and ask a doctor if rash occurs
Dosage & Administration
spray generously and spread evenly by hand 15 minutes before sun exposure
hold container 4 to 6 inches from the skin to apply
do not spray directly into face. Spray on hands then apply to face
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 your time in the sun, especially from 10 a.m. – 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
Inactive Ingredient
WATER
CYCLOPENTASILOXANE
TRIETHOXYCAPRYLYLSILANE
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE
CETYL ETHYLHEXANOATE
BUTYLENE GLYCOL
CETYL PEG/PPG-10/1 DIMETHICONE
PEG-10 DIMETHICONE
SORBITAN ISOSTEARATE
SODIUM CHLORIDE
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
DISTEARDIMONIUM HECTORITE
WATER
TOCOPHERYL ACETATE
Package Label.Principal Display Panel
Labeling (84090 001 01)
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