Pacific Mango Sunscreen Spf 30 Cream
FDA Label NDC 85217-584

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by San Diego Natural Soap Company for the product Pacific Mango Sunscreen Spf 30 (NDC 85217-584). 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 active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Avobenzone 3.00%

Octisalate 5.00%

Octocrylene 7.00%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn.
  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of swimming or sweating
  • 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.

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.

Stop Use And Ask A Doctor If

  • rash or irritation develops and lasts.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast-Feeding,

ask a health professional before use

Directions

  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Sun Protection Measures.Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with 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-sleeved shirts, pants, hats, and sunglasses.

Other Information

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aleurites Moluccanus Seed Oil, Aloe Barbadensis Leaf Juice, Arachidyl Alcohol, Arachidyl Glucoside, Behenyl Alcohol, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Camellia Sinensis Leaf Extract, Cetearyl Alcohol, Decyl Glucoside, Dimethicone, Dodecane, Ethylhexylglycerin, Fragrance (Parfum), Glycerin, Glyceryl Stearate SE, Helianthus Annuus (Sunflower) Seed Oil, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Jasminum Officinale (Jasmine) Flower/Leaf Extract, Macadamia Ternifolia Seed Oil, Magnesium Aluminum Silicate, Mangifera Indica (Mango) Fruit Extract, Niacinamide, Panthenol, Phenoxyethanol, Polyhydroxystearic Acid, Potassium Cetyl Phosphate, Prunus Serrulata Flower Extract, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Squalane, Symphytum Officinale Extract, Tetrasodium EDTA, Tocopherol, Tocopheryl Acetate, Water (Aqua), Xanthan Gum

Questions?

(858) 490-0515

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