Bioelements, Inc.
FDA Label NDC 49825-117

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, Inc. (NDC 49825-117). 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, warnings, 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 - Active Ingredient

Active Ingredients         Purpose  

Homosalate 10%            Sunscreen

Octinoxate 7.5%            Sunscreen

Octisalate 5%               Sunscreen

Oxybenzone 6%            Sunscreen

Warnings

Warnings

For external use only.

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

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

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

Indications & Usage

Uses:

for skin highly sensitive to sunburn

Directions:

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

Inactive Ingredient

Water (Aqua) (Eau), Aloe Barbadensis Leaf Juice, Glycerine, Cetyl Alcohol, Stearic Acid, C12-15 Alkyl Benzoate, Retinyl Palmitate, Tocopheryl Acetate, Panax Ginseng (Ginseng) Root Extract, Centella Asiatica (Gatu Kola) Extract, Angelica Polymorpha Sinensis (Dong Quai) Root Extract, Nasturtium Officinale (Watercress) Extract, Rhus Glabra (Sumac) Extract, Chamomilla Recutita (Matricaria) Flower Extract, Dimethicone, Dea-cetyl Phosphate, VP/Eicosene Copolymer, Phenoxyethanol, Butylene Glycol, Triethanolamine, Carbomer, Titanium Dioxide, Glycereth-2 Cocoate, Iodopropynyl Butylcarbamate

Image Of Carton (Carton)

Image Of Carton (Carton)

Package Label.Principal Display Panel

Bioelements

SPF 50

for Maximum UVA/UVB Protection

Antioxidant Moisturizer

73 mL/2.5 Fl. Oz.

Image Of Primary Label (Primary)

Image Of Primary Label (Primary)

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