Redefine Triple Defense Cream
FDA Label NDC 14222-2251

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 14222-2251). 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

→ Purpose

→ Uses

→ Warnings

→ Do Not Use On

→ When Using This Product

→ Stop Use And Ask Doctor If

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Inactive Ingredients

→ Other Information

→ Principal Display Panel - 30 Ml Carton Label

→ Principal Display Panel - 30 Ml Jar Label

Active Ingredients

Avobenzone 3%, Octisalate 5%, Octocrylene 7%

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

Inactive Ingredients

1,2-Hexanediol, Alcohol Denat., Aluminum Starch Octenylsuccinate, Aqua/Eau/Water, Benzoic Acid, Beta Vulgaris (Beet) Root Extract, Biosaccharide Gum-4, Butylene Glycol, Butyloctyl Salicylate, Calcium Gluconate, Carnosine, Cetearyl Alcohol, Cetyl Ethylhexanoate, Chlorphenesin, Cynara Scolymus (Artichoke) Leaf Extract, Dehydroacetic Acid, Diglycerin, Dimethicone, Dimethicone Crosspolymer, Disodium EDTA, Disodium Lauriminodipropionate Tocopheryl Phosphates, Fragrance/Parfum, Fructooligosaccharides, Gluconolactone, Glycerin, HDI/Trimethylol Hexyllactone Crosspolymer, Hydrogenated Polyisobutene, Lactic Acid, Methyl Carboxymethylphenyl Aminocarboxypropyl-phosphonate, Methyl Methacrylate Crosspolymer, Niacinamide, Pentylene Glycol, Phenoxyethanol, Phragmites Karka Extract, Polyacrylate-13, Polyisobutene, Polysorbate 20, Poria Cocos Extract, Potassium Lactate, Propanediol, Red 4 (Cl 14700), Silica, Sodium Acetylated Hyaluronate, Sodium Benzoate, Sodium Chloride, Sodium Polyacryloyldimethyl Taurate, Sodium Stearoyl Glutamate, Sorbitan Isostearate, Vitis Vinifera (Grape) Juice Extract, VP/Eicosene Copolymer, Yellow 5 (Cl 19140).