Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 4ece1847-1c94-4bf7-b936-109556a460a7
Route
TOPICAL
Published
Effective Date 2025-01-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (75 mg) Titanium Dioxide (20 mg) Zinc Oxide (171 mg)
Inactive Ingredients
Cyclomethicone 5 Water Alcohol Glycerin Methyl Methacrylate Peg/ppg-18/18 Dimethicone Echinacea Purpurea .alpha.-tocopherol Acetate Camellia Oleifera Seed Arctostaphylos Uva-ursi Leaf Glycyrrhiza Glabra Stearic Acid Ethylhexylglycerin Caprylyl Glycol Aluminum Hydroxide Phenoxyethanol Hexylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-08-01

Description

Octinoxate 7.5%, Titanium Dioxide 2%, Zinc Oxide 17.1%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 7.5%, Titanium Dioxide 2%, Zinc Oxide 17.1%

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

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove

Section 50570-1

Do not use on damaged or broken skin

Warnings

For external use only

Questions

Call toll free 1-877-650-1837

Directions
  • Shake bottle well
  • Apply to face in the morning or prior to sun exposure
  • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating
    • Children under 6 months: Ask a doctor
    • This lightweight fluid can be used alone, over skincare products and under makeup.
  • 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.
Other Information

Protect this product from excessive heat and direct sun.

Active Ingredients

Octinoxate 7.5%, Titanium Dioxide 2%, Zinc Oxide 17.1%

Inactive Ingredients:

Cyclopentasiloxane, Water (Aqua, Eau), Alcohol Denat., Glycerin, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Methyl Methacrylate Crosspolymer, PEG/PPG-18/18 Dimethicone, PEG-9 Polydimethylsiloxyethyl Dimethicone, Parachlorella Beijerinckii Exopolysaccharides, Echinacea Purpurea Extract, Tocopheryl Acetate, Camellia Oleifera Leaf Extract, Arctostaphylos Uva Ursi Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Stearic Acid, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, BHT, Ethylhexylglycerin, Caprylyl Glycol, Aluminum Hydroxide, Phenoxyethanol, Hexylene Glycol, Fragrance (Parfum), Hexyl Cinnamal, Linalool.

Principal Display Panel – 30 Ml Jar Label

SUBLIME

DEFENSE

Ultra Lightweight

UV Defense Fluid

Fluide UV Défense

Ultra Léger

Sunscreen Broad Spectrum

SPF 50

Écran Solaire Large Spectre

FPS 50

ALGENIST

Biotechnology from

San Francisco

Principal Display Panel – 30 Ml Carton Label

URBAN PROTECTION

SUBLIME DEFENSE

Ultra Lightweight

UV Defense Fluid

Sunscreen Broad Spectrum

SPF 50

ALGENIST

with Alguronic Acid

1 US fl. oz. / 30 ml


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

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Purpose

Sunscreen

Warnings

For external use only

Questions

Call toll free 1-877-650-1837

Directions
  • Shake bottle well
  • Apply to face in the morning or prior to sun exposure
  • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating
    • Children under 6 months: Ask a doctor
    • This lightweight fluid can be used alone, over skincare products and under makeup.
  • 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.
Other Information

Protect this product from excessive heat and direct sun.

Active Ingredients

Octinoxate 7.5%, Titanium Dioxide 2%, Zinc Oxide 17.1%

Inactive Ingredients:

Cyclopentasiloxane, Water (Aqua, Eau), Alcohol Denat., Glycerin, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Methyl Methacrylate Crosspolymer, PEG/PPG-18/18 Dimethicone, PEG-9 Polydimethylsiloxyethyl Dimethicone, Parachlorella Beijerinckii Exopolysaccharides, Echinacea Purpurea Extract, Tocopheryl Acetate, Camellia Oleifera Leaf Extract, Arctostaphylos Uva Ursi Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Stearic Acid, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, BHT, Ethylhexylglycerin, Caprylyl Glycol, Aluminum Hydroxide, Phenoxyethanol, Hexylene Glycol, Fragrance (Parfum), Hexyl Cinnamal, Linalool.

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

SUBLIME

DEFENSE

Ultra Lightweight

UV Defense Fluid

Fluide UV Défense

Ultra Léger

Sunscreen Broad Spectrum

SPF 50

Écran Solaire Large Spectre

FPS 50

ALGENIST

Biotechnology from

San Francisco

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

URBAN PROTECTION

SUBLIME DEFENSE

Ultra Lightweight

UV Defense Fluid

Sunscreen Broad Spectrum

SPF 50

ALGENIST

with Alguronic Acid

1 US fl. oz. / 30 ml


Advanced Ingredient Data


Raw Label Data

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