REDEFINE TRIPLE DEFENSE- avobenzone, octisalate, octocrylene cream

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]

Active ingredients

Avobenzone 3%

Octisalate 5%

Octocrylene 7%

Purpose

Sunscreen

Sunscreen

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

• 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 the product in this container from excessive heat and direct sun

Inactive ingredients

1,2-hexanediol, alcohol denat., aluminum starch octenylsuccinate, 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 aminocarboxypropylphosphonate, methyl methacrylate crosspolymer, niacinamide, pentylene glycol, phenoxyethanol, phragmites karka extract, polyacrylate-13, polyisobutene, polysorbate 20, poria cocos extract, potassium lactate, propanediol, red 33 (Cl 17200), silica, sodium acetylated hyaluronate, sodium benzoate, sodium chloride, sodium polyacryloyldimethyl taurate, sodium stearoyl glutamate, sorbitan isostearate, tocopherol, vitis vinifera (grape) juice extract, VP/eicosene copolymer, yellow 5 (Cl 19140)

Questions?

1-888-995-5656

Principal Display Panel - 15 mL Carton Label

RODAN+FIELDS

REDEFINE
30-DAY REGIMEN
FOR SIGNS OF AGING

FEMALE FOUNDED + DERMATOLOGIST DEVELOPED

91%
NOTICED
FIRMER
SKIN**

DAILY CLAY
CLEANSER
65 ML/2.2 FL. OZ.

PORE
REFINING TONER
60 ML/2 FL. OZ.

TRIPLE DEFENSE CREAM
BROAD SPECTRUM SPF 30
SUNSCREEN

15 ML/0.5 FL. OZ.

OVERNIGHT
RESTORATIVE CREAM

15 ML/0.5 FL. OZ.

Principal Display Panel - 15 mL Jar Label

RODAN+FIELDS

REDEFINE 3 AM

Triple Defense Cream Broad Spectrum SPF 30 Sunscreen

INGREDIENTS AND APPEARANCE

REDEFINE TRIPLE DEFENSE 
avobenzone, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14222-2251
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
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALCOHOL (UNII: 3K9958V90M)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
WATER (UNII: 059QF0KO0R)
BENZOIC ACID (UNII: 8SKN0B0MIM)
BETA VULGARIS (UNII: 4G174V5051)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CALCIUM GLUCONATE (UNII: SQE6VB453K)
CARNOSINE (UNII: 8HO6PVN24W)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
CHLORPHENESIN (UNII: I670DAL4SZ)
CYNARA SCOLYMUS LEAF (UNII: B71UA545DE)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
DIGLYCERIN (UNII: 3YC120743U)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE CROSSPOLYMER (450000 MPA.S) (UNII: UF7620L1W6)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES (UNII: 0K5Y9U1P6M)
BETA VULGARIS ROOT FRUCTOOLIGOSACCHARIDES (UNII: N2UDM48ZD6)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
METHYL CARBOXYMETHYLPHENYL AMINOCARBOXYPROPYLPHOSPHONATE (UNII: K48QWH6YGJ)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
NIACINAMIDE (UNII: 25X51I8RD4)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PHRAGMITES KARKA WHOLE (UNII: 10086A360Y)
POLYACRYLATE-13 (UNII: FS2D4T67EA)
POLYISOBUTYLENE (2300 MW) (UNII: DSQ2V1DD1K)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
FU LING (UNII: XH37TWY5O4)
POTASSIUM LACTATE (UNII: 87V1KMK4QV)
PROPANEDIOL (UNII: 5965N8W85T)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: NG5NG5733T)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
TOCOPHEROL (UNII: R0ZB2556P8)
WINE GRAPE JUICE (UNII: JHQ6158A7R)
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14222-2251-1	1 in 1 CARTON	10/18/2020
1		30 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC: 14222-2251-2	1 in 1 CARTON	06/01/2021
2		7 mL in 1 JAR; Type 0: Not a Combination Product
3	NDC: 14222-2251-3	2 mL in 1 PACKET; Type 0: Not a Combination Product	04/12/2022
4	NDC: 14222-2251-4	1 in 1 CARTON	01/03/2025
4		15 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 Drug	M020	10/18/2020

Labeler - Rodan & Fields (051659584)