Otc - Purpose
| ACTIVE INGREDIENTS | |
|---|---|
| OCTINOXATE 7.5% | Sunscreen |
| TITANIUM DIOXIDE 8.0% | Sunscreen |
Bio Beauty Bio Defense
FDA Label NDC 52424-0002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Libinvest for the product Bio Beauty Bio Defense (NDC 52424-0002). 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 - purpose, uses, warnings, otc - stop use, otc - keep out of reach of children, directions, inactive ingredients, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
Use as a foundation, helps prevent sunburn, higher SPF gives more sunburn protection.
Warnings
For external use only. Not to be swallowed. Avoid contact with the eyes.
Otc - Stop Use
Stop use and ask doctor if rash develops and lasts.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
Use in place of your normal foundation.
Inactive Ingredients
WATER, GLYCERYL STEARATE/ISOPROPYLENE GLYCOL STEARATE/GLYCERYLISOSTEARATE/OLETH-25/CETETH-25, ISODECETH-6, OLETH-10, ALUMINUM STEARATE, ALUMINA, SIMETHICONE, PROPYLENE GLYCOL DIPELARGONATE, METHYL METHACRYLATE CROSSPOLYMER, OCTYLDODECYL MYRISTATE, PALMITOYL PROLINE and MAGNESIUM PALMITOYL GLUTAMATE and SODIUM PALMITOYL SARCOSINATE, IRON OXIDES, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOLDIMETHYL TAURATE COPOLYMER, SQUALANE, POLYSORBATE 60, BENZOPHENONE-3, GLYCERYL STEARATE and BEHENYL LAURYL MYRISTYL CETYL ALCOHOL and PALMITIC STEARIC ACID and LECITHIN, MAGNESIUM ALUMINUM SILICATE, BUTYROSPERMUM PARKII (SHEA BUTTER), CETYL ALCOHOL, PHENOXYETHANOL, METHYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, BUTYLPARABEN, ISOBUTYLPARABEN, FRAGRANCE, TOCOPHERYL ACETATE, GUM XANTHAN, ALLANTION, METHYLISOTHIAZOLINONE.
Other
Distributed by Primo Derma, Inc. Santa Ana, CA 92705
Tel: ++001-714-560 0111
Principal Display Panel - 50 Ml Label
Tinted
Cream Foundation
Sun Protectant
SPF 18
Principal Display Panel (50 ml Label)
Principal Display Panel - 150 Ml Label
Tinted
Cream Foundation
Sun Protectant
SPF 18
Principal Display Panel (150 ml Label)
* Please review the disclaimer below.
