ed0209a6-a8ce-4394-bcf0-32d585a6b834

SPL v4
SPL
SPL Set ID ed0209a6-a8ce-4394-bcf0-32d585a6b834
Route
topical
Published
Effective Date 2023-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (0.02 g) homosalate (0.068 g) octocrylene (0.044 g) octisalate (0.034 g)
Inactive Ingredients
water glycerin alkyl (c12-15) benzoate silicon dioxide niacinamide dimethicone hydrogenated soybean lecithin diglycerin benzyl alcohol titanium dioxide phenoxyethanol butylene glycol aminomethylpropanol tocopherol soybean oil sodium benzoate xanthan gum propanediol carboxypolymethylene carnosine sodium acetylated hyaluronate polyisobutylene (2300 mw) citric acid monohydrate potassium lactate disodium lauriminodipropionate tocopheryl phosphates cynara scolymus leaf lactic acid, unspecified form sorbitan isostearate 1,2-hexanediol polysorbate 20 biosaccharide gum-4 gluconolactone polysorbate 60 benzoic acid calcium gluconate dehydroacetic acid

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-10-18
Purpose

Sunscreen

Description

Drug Facts

Medication Information

Warnings

For external use only.

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.
Purpose

Sunscreen

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.

Description

Drug Facts

Questions?

1-888-995-5656

Section 42229-5

Drug Facts

Do Not Use On
  • damaged or broken skin.
Active Ingredients

Avobenzone 2%,

Homosalate 6.8%,

Octisalate 3.4%,

Octocrylene 4.4%

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.

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

Structured Label Content

Warnings

For external use only.

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.
Purpose

Sunscreen

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

Section 42229-5 (42229-5)

Drug Facts

Do Not Use On (Do not use on)
  • damaged or broken skin.
Active Ingredients

Avobenzone 2%,

Homosalate 6.8%,

Octisalate 3.4%,

Octocrylene 4.4%

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.
Keep Out of Reach of Children. (Keep out of reach of children.)

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

Principal Display Panel – 30 Ml Carton Label (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 (Principal Display Panel – 30 mL Bottle Pump Label)

RODAN + FIELDS

REDEFINE

Triple Defense Lotion Broad Spectrum SPF 30

3 AM

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:31.244332 · Updated: 2026-03-14T23:02:06.847821