REDEFINE triple defense by Rodan & Fields

REDEFINE triple defense by

Drug Labeling and Warnings

REDEFINE triple defense by is a Otc medication manufactured, distributed, or labeled by Rodan & Fields. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

REDEFINE TRIPLE DEFENSE- avobenzone, octisalate, octocrylene cream 
Rodan & Fields

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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.

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).

Other Information

Protect this product from excessive heat and direct sun.

Principal Display Panel - 30 mL carton

REDEFINE TRIPLE DEFENSE 
avobenzone, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-4300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.07 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.05 g  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.03 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
NIACINAMIDE (UNII: 25X51I8RD4)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
DIGLYCERIN (UNII: 3YC120743U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
BETA VULGARIS (UNII: 4G174V5051)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
CHLORPHENESIN (UNII: I670DAL4SZ)
PROPANEDIOL (UNII: 5965N8W85T)
CARNOSINE (UNII: 8HO6PVN24W)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
POLYISOBUTYLENE (2300 MW) (UNII: DSQ2V1DD1K)
POTASSIUM LACTATE (UNII: 87V1KMK4QV)
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)
CYNARA SCOLYMUS LEAF (UNII: B71UA545DE)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
BENZOIC ACID (UNII: 8SKN0B0MIM)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-4300-2	1 in 1 CARTON	10/01/2020
1	NDC: 14222-4300-1	30 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	10/01/2020	12/20/2021

Labeler - Rodan & Fields (051659584)

Revised: 12/2021

Document Id: a0b39fca-2034-4ce5-8932-316fb55ec162

34390-5

Set id: 19e6f416-cfee-4328-a9da-4717a87e7267

Version: 5

Effective Time: 20211220