REDEFINE TRIPLE DEFENSE- avobenzone, homosalate, octocrylene, octisalate lotion

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]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Avobenzone 2%,

Homosalate 6.8%,

Octisalate 3.4%,

Octocrylene 4.4%

Purpose

Sunscreen

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 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

• 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 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 Lauriminodipropionate Tocopheryl Phosphates, Fragrance/Parfum, Fructooligosaccharides, Gluconolactone, Glycerin, Glycine Soja (Soybean) Oil, Hydrogenated Lecithin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Lactic Acid, Methyl Carboxymethylphenyl Aminocarboxypropylphosphonate, Niacinamide, Phenoxyethanol, Phragmites Karka Extract, Po yacrylate-13, Polyisobutene, Po ysorbate 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.

Questions?

1-888-995-5656

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 Lotion Broad Spectrum SPF 30

3 AM

INGREDIENTS AND APPEARANCE

REDEFINE TRIPLE DEFENSE 
avobenzone, homosalate, octocrylene, octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-2252
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.02 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.068 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.044 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.034 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NIACINAMIDE (UNII: 25X51I8RD4)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
DIGLYCERIN (UNII: 3YC120743U)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
TOCOPHEROL (UNII: R0ZB2556P8)
SOYBEAN OIL (UNII: 241ATL177A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
XANTHAN GUM (UNII: TTV12P4NEE)
PROPANEDIOL (UNII: 5965N8W85T)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CARNOSINE (UNII: 8HO6PVN24W)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
POLYISOBUTYLENE (2300 MW) (UNII: DSQ2V1DD1K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM LACTATE (UNII: 87V1KMK4QV)
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)
CYNARA SCOLYMUS LEAF (UNII: B71UA545DE)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
POLYSORBATE 60 (UNII: CAL22UVI4M)
BENZOIC ACID (UNII: 8SKN0B0MIM)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-2252-1	1 in 1 CARTON	10/18/2020
1		30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/18/2020

Labeler - Rodan & Fields (051659584)