Spf 50 Face Sunscreen Cream
FDA Label NDC 49825-201

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 Spf 50 Face Sunscreen (NDC 49825-201). 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

Avobenozone 3.0% ............. Sunscreen

Homosalate 10%   .............. Sunscreen

Octinoxate 7.0% ............... Sunscreen

Octisalate 5.0% ................ Sunscreen

Octocrylene 5.0% ............. Sunscreen

Oxybenzone 6.0% ............. Sunscreen

Otc - Purpose

Uses

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

Indications & Usage

Stop use and ask a doctor if rash occurs

Warnings

Warnings

  • For external use only
  • Do not use on damaged or broken skin
  • When using this product keep out of eyes. Rinse with water to remove.

Dosage & Administration

Directions

  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Children under 6 months: Ask a doctor
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10a.m. - 2p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredient

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice Powder, Aminomethyl Propanol, Angelica Polymorpha Sinensis (Dong Quai) Root Extract, Ascorbyl Palmitate, Buylene Glycol, Centella Asiatica (Gotu Kola) Extract, Cetyl Dimethicone, Chamomilla Recutita (Matricaria) Flower Extract, Chlorphenesin, Disodium EDTA, Glycerin, Nasturtium Officinale (Watercress) Extract, Panax Ginseng (Genseng) Root Extract, Phenoxyethanol, Phospholipids, Retinyl Palmitate, Rhus Glabra (Sumac) Extract, Steareth-2, Steareth-21, Tocopheryl Acetate, Water (Aqua, Eau)

Package Label.Principal Display Panel

Bioelements

SPF 50 FaceScreen

Broad Spectrum

SPF 50 Sunsceen

Daily anitioxidant moisturizer

68 mL/ 2.3 Fl. Oz.

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