Oxygenetix Oxygenating Foundation Lotion
FDA Label NDC 10258-101

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Colonial Dames Co Ltd for the product Oxygenetix Oxygenating Foundation (NDC 10258-101). 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, indications & usage, warnings, otc - keep out of reach of children, directions, 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 - Active Ingredient

ACTIVE INGREDIENT

SALICYLIC ACID 2%

Otc - Purpose

PURPOSE
ACNE TREATMENT

Indications & Usage

USES

  • FOR THE TREATMENT OF ACNE.

Warnings

WARNINGS
FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES. DISCONTINUE USE IF SIGNS OF IRRITATION OR RASH APPEAR.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Directions

APPLY WITH CLEAN SPONGE OR FINGERTIPS. BLEND UNTIL EVEN. FINISH BY APPLYING MORE IF NEEDED, FOR MAXIMUM COVERAGE.

Inactive Ingredient

INACTIVE INGREDIENTS
ALOE BARBADENSIS GEL, ISODODECANE, TITANIUM DIOXIDE, METHICONE, POLYGLYCERYL-4 ISOSTEARATE, CETYL DIMETHICONE COPOLYOL, HEXYL LAURATE, CYCLOPENTASILOXANE, PEG/PPG-20/15 DIMETHICONE, SACCHAROMYCES CEREVISIAE, PEG-8, DIOCTYLDODECYL DODECANEDIOATE, IRON OXIDES, VITIS VINIFERA (GRAPE) SEED EXTRACT, GLYCERIN, O-CYMEN-5-OL, SILICA, CYCLOMETHICONE, DISTEARDIMONIUM HECTORITE, PROPYLENE CARBONATE, MARIS SAL, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER.

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