Bioelements
FDA Label NDC 49825-114

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bioelements Inc. for the product Bioelements (NDC 49825-114). 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, indications & usage, warnings, dosage & administration, 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 Ingredients                           Purpose

Octinoxate 7.5 %                           Sunscreen

Octisalate 5%                                Sunscreen

Oxybenzone 3%                            Sunscreen

Titanium Dioxide 0.01%                  Sunscreen

zinc Oxide 0.01%                           Sunscreen

Otc - Purpose

Uses

For skin highly sensitive to sunburn

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed get medical help or contact poison control center right away.

Indications & Usage

Stop use and ask a doctor if rash and irritation develops and lasts

Warnings

Warnings

For external use only.

When using this product: keep out of eyes. Rinse with water to remove.

Dosage & Administration


Directions

Apply liberally 30 minutes before sun exposure. Reapply as needed or after towel drying, swimming  or perspiring. Children under 6 months, ask a doctor.

Inactive Ingredient

Inactive IngredientsWater (aqua) (eau), sorbitol, c12-15 alkyl benzoate, DEA cetyl phosphate, stearic acid, cetyl alcohol, dimethicone, carbomer, Lavendula Augustifolia (Lavender) oil, Salvia Officinalis (sage) Oil, Salvia sclarea (clary sage) oil, Citrus aurantium (petitgrain cordillera) oil, Citrus Aurantium (neroli) oil, Lavendula Hybridia (Lavendin) Oil, Imidazolidinyl Urea, Methylparaben, Propylparaben, Triethanolamine.

Package Label.Principal Display Panel

Sun Diffusing Protector SPF 15

Broad Spectrum UVA/UVB protection

Moisturizing Formula

177 mL / 6 Fl. Oz.


Image Of Front Label (Front)

Image Of Front Label (Front)


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