Otc - Active Ingredient
Zinc Oxide-15%
Pure Sol Spf 30 Mineral Whipped Sunscreen (shimmer) Spray
FDA Label NDC 84090-002
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 30 Mineral Whipped Sunscreen (shimmer) (NDC 84090-002). 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, indications & usage, inactive ingredient, dosage & administration, 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 • higher SPF gives more sunburn - protection • helps protect the skin against the harmful effects of - UVA and UVB rays
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or
contact a Poison Control Center immediately.
Warnings
For external use only
When using this product
avoid contact with the eyes. If contact
occurs rinse thoroughly with water.
Stop use and ask a doctor if
rash or irritation develops and lasts.
Indications & Usage
apply generously and evenly to all exposed areas before sun
exposure • reapply as needed or after towel drying, swimming,
perspiring or vigorous activity • children under 6 months of age:
ask a doctor
Inactive Ingredient
Water (Aqua)
Butane
Isobutane
Propane
Glycerin
PEG-17 Dimethicone
Propylene Glycol
Stearic Acid
Palmitic Acid
Triethanolamine
Glyceryl Stearate
PEG-100 Stearate
PEG-7 Glyceryl Cocoate
Jojoba Wax PEG-120 Esters
Cetearyl Alcohol
Hydroxyacetophenone
1,2-Hexanediol
Butylene Glycol
Gentiana Scabra Root Extract
Dipotassium Glycyrrhizate
Calcium SodiumBorosilicate
Silver
Sodium Hyaluronate
Disodium EDTA
Hibiscus Esculentus Fruit Extract
Dosage & Administration
Apply generously and evenly over whole body 20 minutes before sun exposure. Reapply frequently.
Package Label.Principal Display Panel
Labeling (84090 002 01)
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