Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID d1dd62c6-33ac-4941-ab99-9eb8cc3c208a
Route
TOPICAL
Published
Effective Date 2026-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (0.07 g) Octisalate (0.05 g) Avobenzone (0.03 g)
Inactive Ingredients
1,2-hexanediol Alcohol Aluminum Starch Octenylsuccinate Water Benzoic Acid Beta Vulgaris Biosaccharide Gum-4 Butylene Glycol Butyloctyl Salicylate Calcium Gluconate Carnosine Cetostearyl Alcohol Cetyl Ethylhexanoate Chlorphenesin Cynara Scolymus Leaf Dehydroacetic Acid Diglycerin Dimethicone Dimethicone Crosspolymer (450000 Mpa.s) Edetate Disodium Anhydrous Disodium Lauriminodipropionate Tocopheryl Phosphates Beta Vulgaris Root Fructooligosaccharides Gluconolactone Glycerin Hexamethylene Diisocyanate/trimethylol Hexyllactone Crosspolymer Hydrogenated Polybutene (1300 Mw) Lactic Acid, Unspecified Form Methyl Carboxymethylphenyl Aminocarboxypropylphosphonate Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Niacinamide Pentylene Glycol Phenoxyethanol Phragmites Karka Whole Polyacrylate-13 Polyisobutylene (2300 Mw) Polysorbate 20 Fu Ling Potassium Lactate Propanediol D&c Red No. 33 Silicon Dioxide Sodium Acetylated Hyaluronate Sodium Benzoate Sodium Chloride Sodium Polyacryloyldimethyl Taurate Sodium Stearoyl Glutamate Sorbitan Isostearate Tocopherol Wine Grape Juice Eicosyl Povidone Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-18
Description

Avobenzone 3% Octisalate 5% Octocrylene 7%

Purpose

Sunscreen Sunscreen Sunscreen

Medication Information

Purpose

Sunscreen

Sunscreen

Sunscreen

Description

Avobenzone 3% Octisalate 5% Octocrylene 7%

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

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only

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
Do Not Use
  • on damaged or broken skin
Questions?

1-888-995-5656

Other Information

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

Active Ingredients

Avobenzone 3%

Octisalate 5%

Octocrylene 7%

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)

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If
  • rash occurs
Principal Display Panel 15 Ml Jar Label

RODAN+FIELDS

REDEFINE 3 AM

Triple Defense Cream Broad Spectrum SPF 30 Sunscreen

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.

Structured Label Content

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

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Sunscreen

Sunscreen

Sunscreen

Warnings

For external use only

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
Do Not Use (Do not use)
  • on damaged or broken skin
Questions?

1-888-995-5656

Other Information (Other information)

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

Active Ingredients (Active ingredients)

Avobenzone 3%

Octisalate 5%

Octocrylene 7%

Inactive Ingredients (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)

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash occurs
Principal Display Panel 15 Ml Jar Label (Principal Display Panel - 15 mL Jar Label)

RODAN+FIELDS

REDEFINE 3 AM

Triple Defense Cream Broad Spectrum SPF 30 Sunscreen

Principal Display Panel 15 Ml Carton Label (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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:31.415955 · Updated: 2026-03-14T23:12:46.294226