Ray Defense Cream
FDA Label NDC 49825-138

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 for the product Ray Defense (NDC 49825-138). 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

Avobenzone 2.0% ......... Sunscreen

Octinoxate 7.5% ........... Sunscreen

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

Octocrylene 7.0% ......... Sunscreen

Oxybenzone 5.0% ........ Sunscreen

Otc - Purpose

  • 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

- 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

  • Apply liberally 15 minutes before sun exposure
  • Use a water resistan 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 10 a.m - 2 p.m.
  • Wear long-sleeve shirts, pants, hats, and sunglasses 

Inactive Ingredient

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Extract, C12-15 Alkyl Benzoate, Camellia Oleifera Leaf Extract, Caprylic/Capric Triglyceride, Carbomer, Cetyl Alcoho, Cahmomilla Recutita (Matricaria) Flower Extract, Citrus Aurantium Amara (Bitter Orange) Flower Oil, Citrus Reticulata (Tangerine) Leaf Oil, Cyclopentasiloxane Dimethicone, Dimethiconol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Glycol Distearate, Isohexadecane, Lavandula Angustifolia (Lavender) Oil, Lavandula Hybrida Oil, PEG-100 Stearate, Polysorbate 80, Potassium Cetyl Phosphate, Phenoxyethanol, Salvia Officinalis (Sage) Oil, Salvia Sclarea (Clary) Oil, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Hydroxide, Stearyl Alcohol, Tetrasodium EDTA, Titanium Dioxide, Tocopheryl Acetate, Water (Aqua, Eau)

Package Label.Principal Display Panel

Ray Defense

Broad Spectrum

SPF 30 Sunscreen

59 mL. / 2 Fl. OZ

Primary (Tube)

Primary (Tube)

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