Redefine Triple Defense Lotion
FDA Label NDC 14222-2252

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rodan & Fields for the product Redefine Triple Defense (NDC 14222-2252). 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 ingredients, purpose, uses, warnings, do not use on, when using this product, stop use and ask doctor if, otc - 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 Ingredients

Avobenzone 2%, Homosalate 6.8 %, Octisalate 3.4%, Octocrylene 4.4%

Purpose

Sunscreens

Uses

  • Helps prevent sunburn.
  • When 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 Doctor If

  • rash occurs.

Otc - Keep Out Of Reach Of Children

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

Directions

  • Every AM, apply liberally and evenly over face + neck at least 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • 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-sleeve shirts, pants, hats and sunglasses
  • Children under 6 months: Ask a doctor

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

1,2-Hexanediol, Aminomethyl Propanol, Aqua/Eau/Water, Benzoic Acid, Benzyl Alcohol, Beta Vulgaris (Beet) Root Extract, Biosaccharide Gum-4, Butylene Glycol, C12-15 Alkyl Benzoate, Calcium Gluconate, Carbomer, Carnosine, Citric Acid, Cynara Scolymus (Artichoke) Leaf Extract, Dehydroacetic Acid, Diglycerin, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium EDTA, Disodium Lauriminodipropionate Tocopheryl Phosphates, Fragrance/Parfum, Fructooligosaccharides, Gluconolactone, Glycerin, Hydrogenated Lecithin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Lactic Acid, Methyl Carboxymethylphenyl Aminocarboxypropylphosphonate, Niacinamide, Phenoxyethanol, Phragmites Karka Extract, Polyacrylate-13, Polyisobutene, Polysorbate 20, Polysorbate 60, Poria Cocos Extract, Potassium Lactate, Propanediol, Silica, Sodium Acetylated Hyaluronate, Sodium Benzoate, Sodium Carbomer, Sodium Potassium Aluminum Silicate, Sorbitan Isostearate, Titanium Dioxide (Cl 77891), Tocopherol, Vitis Vinifera (Grape) Juice Extract, Xanthan Gum.

Principal Display Panel – 30 Ml Carton Label

RODAN + FIELDS

REDEFINE

Triple Defense Lotion
Broad Spectrum SPF 30

3 AM

30 mL/1 Fl. Oz. U.S.

Principal Display Panel – 30 Ml Bottle Pump Label

RODAN + FIELDS

REDEFINE

Triple Defense Cream Broad Spectrum SPF 30

3 AM

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