Active Ingredient
Octinoxate 7.5
Oxybenzone 2.0
Cream
FDA Label NDC 61354-025
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oxygen Development for the product Cream (NDC 61354-025). 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 active ingredient, purpose, uses, directions, ingredients, package, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Uses
helps prevent sunburn. Provides moderate protection against sunburn.
Directions
Apply and blend evenly onto the face. Use over Studiomakeup soft illusion Face Primer for a flawless and smooth finish
Ingredients
Water/Aqua, phenyl trimethicone, ethylhexyl methoxycinnamate, dimethicone, dicaprylyl ether, boron nitride, benzophenone-3, polymethylsilsesquioxane, silica, mica, aloe barbadensis leaf juice, disteardimonium hectorite, phenoxyethanol, dimethicone/PEG-10/15 crosspolymer, isododecane, sodium chloride, polyglyceryl-4 isostearate, hexyl laurate, cetyl PEG/PPG-10/1 dimethicone, propylene carbonate, dimethicone crosspolymer, polyethylene, polysilicone-11, ethylhexyglycerin, aluminum dimyristate, triehoxycaprylylsilane,disodium stearoyl glutamate, disodium EDTA, citric acid, potassium sorbate, sodium benzoate, sodium hyaluronate. May contain [+/-]: titanium dioxide CI 77891, iron oxides CI 77491/ CI 77492/ CI 77499
Package
61354-021-01_aw (Art 050 Lbl Upc 177)
61354-021-01_aw (Art 050 Tub 157 Page 1)
61354-021-01_aw (Art 050 Tub 157 Page 2)
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