revlon illuminance serum tint broad spectrum 15 (shade: rich sand)

revlon illuminance serum tint broad spectrum 15 (shade: rich sand)
SPL v1
SPL
SPL Set ID 2a0b6ba3-b5da-f2f7-e063-6394a90a86ae
Route
topical
Published
Effective Date 2024-03-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (0.868 g) zinc oxide (0.28 g) octinoxate (1.54 g)
Inactive Ingredients
trimethylsiloxysilicate (m/q 0.6-0.8) glycerin mica cyclomethicone 6 dimethicone cyclomethicone 5 edetate sodium .alpha.-tocopherol acetate trehalose urea 1,2-hexanediol aluminum oxide disteardimonium hectorite lecithin, soybean ginger citral ferric oxide red dimethiconol (100000 cst) hexylene glycol hyaluronate sodium tetrahexyldecyl ascorbate ferric oxide yellow phenoxyethanol water peg/ppg-18/18 dimethicone alcohol peg-10 dimethicone (600 cst) caprylyl glycol ethylene brassylate phenyl trimethicone hydrogen dimethicone (13 cst) sea salt polyquaternium-51 (2-methacryloyloxyethyl phosphorylcholine/n-butyl methacrylate; 3:7) triethyl citrate bismuth oxychloride ferrosoferric oxide magnesium sulfate, unspecified methicone (20 cst) niacinamide dimethicone/vinyl dimethicone crosspolymer (soft particle) carrageenan sodium pyrrolidone carboxylate triethoxycaprylylsilane

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-03-26

Purpose

Sunscreen

Description

Active Ingredients Purpose Octinoxate 5.5% ...............Sunscreen Titanium dioxide 3.1%...... Sunscreen Zinc oxide (nano) 1.0 %.....Sunscreen


Medication Information

Warnings

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.
Uses

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.
Purpose

Sunscreen

Directions

Directions

  • Apply liberally 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-sleeved shirts, pants, hats, and sunglasses
  • Children under 6 months of age: Ask a doctor

Other Information

Other information:

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

Inactive Ingredients

Inactive Ingredients: Cyclohexasiloxane, Aqua/Water/Eau, Trimethylsiloxysilicate, Glycerin, Mica, PEG-10 Dimethicone, Dimethicone, Phenyl Trimethicone, PEG/PPG-18/18 Dimethicone, 1,2-Hexanediol, Alcohol Denat., Alumina, Caprylyl Glycol, Cyclopentasiloxane, Dimethiconol, Disteardimonium Hectorite, Ethylene Brassylate, Hexylene Glycol, Hydrogen Dimethicone, Lecithin, Magnesium Sulfate, Maris Sal/Sea Salt/Sel Marin, Methicone, Niacinamide, Polyquaternium-51, Polysilicone-11, Sodium Carrageenan, Sodium Hyaluronate, Sodium PCA, Tetrahexyldecyl Ascorbate, Tetrasodium EDTA, Tocopheryl Acetate, Trehalose, Triethoxycaprylylsilane, Triethyl Citrate, Urea, Zingiber Officinale (Ginger) Root Extract, Citral, Phenoxyethanol.

MAY CONTAIN/PEUT CONTENIR/PUEDE CONTENER (+/-): [Bismuth Oxychloride (CI 77163), Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Titanium Dioxide (CI 77891).]. B03218

Description

Active Ingredients Purpose Octinoxate 5.5% ...............Sunscreen Titanium dioxide 3.1%...... Sunscreen Zinc oxide (nano) 1.0 %.....Sunscreen

Questions?

Questions?

1-800-473-8566

Monday - Thursday, 10AM - 12PM and 2PM - 4PM EST

Section 43683-2

sections were updated to align with FDAs new section breakdown requirements

Carton Packaging

Carton Packaging

Active Ingredients

Active Ingredients Purpose

Octinoxate 5.5% ...............Sunscreen

Titanium dioxide 3.1%...... Sunscreen

Zinc oxide (nano) 1.0 %.....Sunscreen

Tube Packaging Label

Keep Out of Reach of Children

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


Structured Label Content

Warnings

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.
Uses

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.
Purpose

Sunscreen

Directions

Directions

  • Apply liberally 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-sleeved shirts, pants, hats, and sunglasses
  • Children under 6 months of age: Ask a doctor

Other Information (Other information)

Other information:

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

Inactive Ingredients (Inactive ingredients)

Inactive Ingredients: Cyclohexasiloxane, Aqua/Water/Eau, Trimethylsiloxysilicate, Glycerin, Mica, PEG-10 Dimethicone, Dimethicone, Phenyl Trimethicone, PEG/PPG-18/18 Dimethicone, 1,2-Hexanediol, Alcohol Denat., Alumina, Caprylyl Glycol, Cyclopentasiloxane, Dimethiconol, Disteardimonium Hectorite, Ethylene Brassylate, Hexylene Glycol, Hydrogen Dimethicone, Lecithin, Magnesium Sulfate, Maris Sal/Sea Salt/Sel Marin, Methicone, Niacinamide, Polyquaternium-51, Polysilicone-11, Sodium Carrageenan, Sodium Hyaluronate, Sodium PCA, Tetrahexyldecyl Ascorbate, Tetrasodium EDTA, Tocopheryl Acetate, Trehalose, Triethoxycaprylylsilane, Triethyl Citrate, Urea, Zingiber Officinale (Ginger) Root Extract, Citral, Phenoxyethanol.

MAY CONTAIN/PEUT CONTENIR/PUEDE CONTENER (+/-): [Bismuth Oxychloride (CI 77163), Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Titanium Dioxide (CI 77891).]. B03218

Questions?

Questions?

1-800-473-8566

Monday - Thursday, 10AM - 12PM and 2PM - 4PM EST

Section 43683-2 (43683-2)

sections were updated to align with FDAs new section breakdown requirements

Carton Packaging

Carton Packaging

Active Ingredients (ACTIVE INGREDIENTS)

Active Ingredients Purpose

Octinoxate 5.5% ...............Sunscreen

Titanium dioxide 3.1%...... Sunscreen

Zinc oxide (nano) 1.0 %.....Sunscreen

Tube Packaging Label

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

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


Advanced Ingredient Data


Raw Label Data

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