Otc - Active Ingredient
Zinc Oxide 3.84%
TITANIUM DIOXIDE 9.36%
Pure Sol Spf 37 Tinted Moisturizer Liquid
FDA Label NDC 84090-004
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 37 Tinted Moisturizer (NDC 84090-004). 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, otc - keep out of reach of children, warnings, dosage & administration, inactive ingredient, indications & usage, 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
WATER /SWEATRESISTANT
TINTED SPFMOISTURIZER
Shields skin from UVA/UVBBlue Light & Infrared Rodiotion
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.lf swallowed, get medical help or contacta Poison Control Center right away
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.lf swallowed, get medical help or contacta Poison Control Center right away
Flammable. Do not spray near heat sparks, sources of ignition, or flames
Dosage & Administration
Apply tiberally 15 minutes before sun exposure.
Reapoly. at least every 2 hours or after 40 minutes of swimming or sweating.
Inactive Ingredient
WATER
ALUMINUM HYDROXIDE
STEARIC ACID
CYCLOPENTASILOXANE
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE
GLYCERIN
CETYL ETHYLHEXANOATE
DIMETHICONE
TRIETHOXYCAPRYLYLSILANE
CETYL PEG/PPG-10/1 DIMETHICONE
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER
SILICA
PEG-10 DIMETHICONE
SODIUM CHLORIDE
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
CI 77492
ISONONYL ISONONANOATE
CETYL PEG/PPG-10/1 DIMETHICONE
POLYHYDROXYSTEARIC ACID
TRIETHOXYCAPRYLYLSILANE
DISTEARDIMONIUM HECTORITE
WATER
CI 77491
ISONONYL ISONONANOATE
DISTEARDIMONIUM HECTORITE
PROPYLENE CARBONATE
CI 77499
POLYHYDROXYSTEARIC ACID
STYRENE/BUTADIENE COPOLYMER
Indications & Usage
Apply liberally 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.
Package Label.Principal Display Panel
Labeling (84090 004 01)
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