Otc - Active Ingredient
Zinc Oxide 7.20%
Pure Sol Spf15 Lip Gloss Pink Coral Liquid
FDA Label NDC 84090-008
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 Spf15 Lip Gloss Pink Coral (NDC 84090-008). 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, indications & usage, 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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Warnings
For external use only
When using this product keep out of eyes.
Rinse with water to remove - do not use on broken skin.
Dosage & Administration
■Apply liberally and evenly 15 minutes before sun exposure.
■Reapply at least every two hours.
■Sun Protection Measures: Spending time in the sun increases
Indications & Usage
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 AM – 2 PM
• wear long sleeve shirts, pants, hats, and sunglasse
Inactive Ingredient
POLYISOBUTENE
TRIDECYL TRIMELLITATE
PHENYL METHICONE
C12-15 ALKYL BENZOATE
CETYL DIMETHICONE
ETHYLHEXYL PALMITATE
SILICA
TRIETHOXYCAPRYLYLSILANE
CETYL PEG/PPG-10/1 DIMETHICONE
PENTAERYTHRITYL TETRA-DI-t-BUTYL HYDROXYHYDROCINNAMATE
CERA MICROCRISTALLINA
PARAFFIN
STEARYL DIMETHICONE
TRIBEHENIN
CERA MICROCRISTALLINA
FLAVOR
SILICA DIMETHYL SILYLATE
CI 77019
CI 77491
DISTEARDIMONIUM HECTORITE
WATER
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
SORBITAN ISOSTEARATE
TOCOPHERYL ACETATE
CI 45380
BHT
CI 45370
Package Label.Principal Display Panel
Labeling (84090 008 01)
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