drug facts

drug facts
SPL v4
SPL
SPL Set ID 9dfe7d50-f347-4671-9657-5e4fbe42b441
Route
topical
Published
Effective Date 2023-11-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (0.1 g) octocrylene (0.05 g) octisalate (0.03 g) avobenzone
Inactive Ingredients
benzyl alcohol butyloctyl salicylate alkyl (c12-15) benzoate dimethicone/bis-isobutyl ppg-20 crosspolymer ethylhexylglycerin glycerin isododecane linoleic acid linolenic acid oleic acid palmitic acid polymethylsilsesquioxane (4.5 microns) silicon dioxide stearic acid tocopherol vinyl dimethicone/methicone silsesquioxane crosspolymer

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-03-10
Purpose

Sunscreen

Description

Avobenzone 3% Homosalate 10% Octisalate 5%, Octocrylene 10%

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
  • Apply liberally over entire face 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 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 this product from excessive heat and direct sun.

Description

Avobenzone 3% Homosalate 10% Octisalate 5%, Octocrylene 10%

Questions?

1-888-995-5656

Section 50565-1

Keep out of reach of children. If swallowed, get medical help right away.

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

Avobenzone 3%

Homosalate 10%

Octisalate 5%,

Octocrylene 10%

Inactive Ingredients:

lsododecane, Dimethicone Crosspolymer, Dimethicone/Bis-lsobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, Silica, C12-15 Alkyl Benzoate, Polysilicone-22, Glycerin, Linoleic Acid, Linolenic Acid, Oleic Acid, Palmitic Acid, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Divinyldimethicone/Dimethicone/Phenylsilsesquioxane Crosspolymer, Polymethylsilsesquioxane, Silica Silylate, Stearic Acid, Tocopherol, Ethylhexylglycerin, Benzyl Alcohol

Stop Use and Ask Doctor
  • if rash occurs.
When Using This Product
  • keep out of eyes. Rinse with water to remove.
Principal Display Panel – 30 Ml Tube Label

RODAN+FIELDS

UNBLEMISH

4

Invisible

Matte Defense

Broad Spectrum SPF 30

Principal Display Panel – 30 Ml Carton Label

RODAN+FIELDS

UNBLEMISH

4

Invisible

Matte Defense

Broad Spectrum SPF 30

RODAN+FIELDS

Gel

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

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
  • Apply liberally over entire face 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 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 this product from excessive heat and direct sun.

Questions?

1-888-995-5656

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help right away.

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

Avobenzone 3%

Homosalate 10%

Octisalate 5%,

Octocrylene 10%

Inactive Ingredients:

lsododecane, Dimethicone Crosspolymer, Dimethicone/Bis-lsobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, Silica, C12-15 Alkyl Benzoate, Polysilicone-22, Glycerin, Linoleic Acid, Linolenic Acid, Oleic Acid, Palmitic Acid, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Divinyldimethicone/Dimethicone/Phenylsilsesquioxane Crosspolymer, Polymethylsilsesquioxane, Silica Silylate, Stearic Acid, Tocopherol, Ethylhexylglycerin, Benzyl Alcohol

Stop Use and Ask Doctor (Stop use and ask doctor)
  • if rash occurs.
When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
Principal Display Panel – 30 Ml Tube Label (Principal Display Panel – 30 mL Tube Label)

RODAN+FIELDS

UNBLEMISH

4

Invisible

Matte Defense

Broad Spectrum SPF 30

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

RODAN+FIELDS

UNBLEMISH

4

Invisible

Matte Defense

Broad Spectrum SPF 30

RODAN+FIELDS

Gel

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:24.465149 · Updated: 2026-03-14T23:01:55.379030