Fermitif Hand Renewal Cream Broad Spectrum Spf 15 Sunscreen
FDA Label NDC 82691-148

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rv Skincare Llc for the product Fermitif Hand Renewal Cream Broad Spectrum Spf 15 Sunscreen (NDC 82691-148). 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 drug facts, active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Avobenzone 3.0% 
Octinoxate 7.5% 
Octisalate 2.0%

Purpose

Sunscreen

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.

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 occurs.

Keep Out Of Reach Of Children.

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

Directions

  • For sunscreen use:
  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply 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 this risk, regularly use a sunscreen with a Broad Spectrum SPF value 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
  • Children under 6 months of age: Ask a doctor

Other Information

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

Inactive Ingredients

Water, Butylene Glycol, Glycerin, C12-15 Alkyl Benzoate, Mangifera Indica (Mango) Seed Butter, Octyldodecyl Neopentanoate, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Aluminum Starch Octenylsuccinate, Hydrogenated Palm Glycerides, Dimethicone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Decapeptide-4, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Sodium Coco PG-Dimonium Chloride Phosphate, Caprylyl Methicone, Squalane, Camellia Sinensis Seed Oil, Caprylyl Glycol, Fragrance, Glyceryl Laurate, Polysilicone-11, Isohexadecane, Carrageenan, Glucose, Polyethylene, Tocopheryl Acetate, Polysorbate 60, Butyrospermum Parkii (Shea) Butter, Jojoba Alcohol, Phenylethyl Resorcinol, Potassium Jojobate, Potassium Sorbate, Propanediol, Simmondsia Chinensis (Jojoba) Butter, Maltodextrin, Disodium EDTA, Pentylene Glycol, Carbomer, Rhodiola Rosea Root Extract, Polysorbate 20, Sodium Hyaluronate, Subtilisin, Citronellol, Geraniol. May Contain (+/-): Red 4, Red 33.

Questions Or Comments?

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