FDA.reportPublic FDA data

REDEFINE Triple Defense

Manufacturer
Rodan & Fields
Effective date
2023-12-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:04:32

Label at a glance#

ProductREDEFINE Triple Defense
Active ingredientAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
Label structure11 sections

Indications and 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.

Dosage and administration

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 i...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2%,

Homosalate 6.8%,

Octisalate 3.4%,

Octocrylene 4.4%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only.

Do not use on

OTC - DO NOT USE SECTION

  • damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-888-995-5656

Principal Display Panel – 30 mL Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN + FIELDS

REDEFINE

Triple Defense Lotion
Broad Spectrum SPF 30

3 AM

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

Principal Display Panel – 30 mL Carton Label
Principal Display Panel – 30 mL Carton Label

Principal Display Panel – 30 mL Bottle Pump Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RODAN + FIELDS

REDEFINE

Triple Defense Lotion Broad Spectrum SPF 30

3 AM

Principal Display Panel – 30 mL Bottle Pump Label
Principal Display Panel – 30 mL Bottle Pump Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
14222-2252-12023-12-14C16284748780-10191ceaa-667d-198a-e063-dbdaa90aec3eed0209a6-a8ce-4394-bcf0-32d585a6b834
14222-2252-12023-07-28C16284748780-10191ceaa-667d-198a-e063-dbdaa90aec3eed0209a6-a8ce-4394-bcf0-32d585a6b834

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14222-2252-1REDEFINE Triple Defense1 in 1 CARTONLOTION14
14222-2252-1REDEFINE Triple Defense30 mL in 1 BOTTLE, PUMPLOTION304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14222-2252REDEFINE TRIPLE DEFENSE (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) LOTION [RODAN & FIELDS]4Current NDC, Legacy NDC, 2 package rows20231215_ed0209a6-a8ce-4394-bcf0-32d585a6b834.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14222-225214222-2252-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
NIACINAMIDE25X51I8RD4IACT
DIMETHICONE92RU3N3Y1OIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
DIGLYCERIN3YC120743UIACT
BENZYL ALCOHOLLKG8494WBHIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
TOCOPHEROLR0ZB2556P8IACT
SOYBEAN OIL241ATL177AIACT
SODIUM BENZOATEOJ245FE5EUIACT
XANTHAN GUMTTV12P4NEEIACT
PROPANEDIOL5965N8W85TIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
CARNOSINE8HO6PVN24WIACT
SODIUM ACETYLATED HYALURONATEWN66R7GL93IACT
POLYISOBUTYLENE (2300 MW)DSQ2V1DD1KIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POTASSIUM LACTATE87V1KMK4QVIACT
DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES0K5Y9U1P6MIACT
CYNARA SCOLYMUS LEAFB71UA545DEIACT
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
POLYSORBATE 207T1F30V5YHIACT
BIOSACCHARIDE GUM-49XRL057X90IACT
GLUCONOLACTONEWQ29KQ9POTIACT
POLYSORBATE 60CAL22UVI4MIACT
BENZOIC ACID8SKN0B0MIMIACT
CALCIUM GLUCONATESQE6VB453KIACT
DEHYDROACETIC ACID2KAG279R6RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REDEFINE Triple DefenseAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATERodan & Fieldsed0209a6-a8ce-4394-bcf0-32d585a6b8342023-12-13WarningsExact identifier
ndc (package): 14222-2252-1
ndc (product): 14222-2252
ndc11 (package): 14222225201
spl id: 3efa9080-5667-4b9d-835b-8ee6157f305b
spl set id: ed0209a6-a8ce-4394-bcf0-32d585a6b834

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.