SPL v2
SPL
SPL Set ID 1d3f87de-90c0-75c0-e063-6394a90a2ef4
Route
TOPICAL
Published
Effective Date 2024-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (80 mg) Avobenzone (30 mg) Homosalate (100 mg) Octisalate (50 mg)
Inactive Ingredients
Maltodextrin Carbomer Homopolymer, Unspecified Type Sodium Stearoyl Glutamate Peg-8 Beeswax Phenoxyethanol Water Isopropyl Palmitate Glycerin Hydroxyacetophenone Citric Acid Monohydrate Trolamine .alpha.-tocopherol Acetate Cetostearyl Alcohol Cyclomethicone 6 Aloe Vera Leaf Cyclomethicone 5 Benzyl Alcohol Mango Polyoxyl 20 Cetostearyl Ether Papaya

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-15

Description

Homosalate 10% Octocrylene 8% Octisalate 5% Avobenzone 3%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate 10% Octocrylene 8% Octisalate 5% Avobenzone 3%

Uses

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun.

Contact

Standard Procedure Inc

2801 Ocean Park Blvd Unit #2062

Santa Monica CA 90405 USA

[email protected]

+1 213-681-1801

Warnings
  • For external use only
  • Do not use on damaged orbroken skin
  • Stop use and ask a doctor if rash occurs
  • When using this product keep out of eyes
  • Rinse with water to remove
Directions
  • Apply generously and evenly 15 minutes before sun exposure
  • Reapply at least every 80 minutes
  • Usa a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures.

    Speading time in the sun increases your risk of skin cancer and early skin aging. To decres this risk, regularly usa a sunscreen with broad spectum SPF of 15 or higher and other sun protection measures including:

    Limit time in thee 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 the product in this container from exessive heat and direct sun

Active Ingredients

Homosalate 10%

Octocrylene 8%

Octisalate 5%

Avobenzone 3%

Inactive Ingredients

BEESWAX, CYCLOPENTASILOXANE, CETEARYL ALCOHOL, ISOPROPYL PALMITATE, CYCLOHEXASILOXANE, CETEARETH-20, ALOE BARBADENSIS LEAF JUICE, ANANAS SATIVUS (PINEAPPLE) FRUIT EXTRACT, BENZYL ALCOHOL, CARBOMER, CARICA PAPAYA (PAPAYA) FRUIT EXTRACT, CITRIC ACID, GLYCERIN, HYDROXYACETOPHENONE, MALTODEXTRIN, MANGIFERA INDICA (MANGO) FRUIT EXTRACT, SODIUM STEAROYL GLUTAMATE, TOCOPHERYL ACETATE, TRIETHANOLAMINE, PHENOXYETHANOL, WATER

Keep Out of Reach of Children

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

Package Label.principal Display Panel

Standard Procedure.

SPF 50+ Sunscreen

Australian Made

Broad Spectrum UVA/UVB Rays

80 minutes Water Resistant


Structured Label Content

Uses

Helps prevent sunburn

If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun.

Contact

Standard Procedure Inc

2801 Ocean Park Blvd Unit #2062

Santa Monica CA 90405 USA

[email protected]

+1 213-681-1801

Purpose

Sunscreen

Warnings
  • For external use only
  • Do not use on damaged orbroken skin
  • Stop use and ask a doctor if rash occurs
  • When using this product keep out of eyes
  • Rinse with water to remove
Directions
  • Apply generously and evenly 15 minutes before sun exposure
  • Reapply at least every 80 minutes
  • Usa a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures.

    Speading time in the sun increases your risk of skin cancer and early skin aging. To decres this risk, regularly usa a sunscreen with broad spectum SPF of 15 or higher and other sun protection measures including:

    Limit time in thee 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 the product in this container from exessive heat and direct sun

Active Ingredients

Homosalate 10%

Octocrylene 8%

Octisalate 5%

Avobenzone 3%

Inactive Ingredients

BEESWAX, CYCLOPENTASILOXANE, CETEARYL ALCOHOL, ISOPROPYL PALMITATE, CYCLOHEXASILOXANE, CETEARETH-20, ALOE BARBADENSIS LEAF JUICE, ANANAS SATIVUS (PINEAPPLE) FRUIT EXTRACT, BENZYL ALCOHOL, CARBOMER, CARICA PAPAYA (PAPAYA) FRUIT EXTRACT, CITRIC ACID, GLYCERIN, HYDROXYACETOPHENONE, MALTODEXTRIN, MANGIFERA INDICA (MANGO) FRUIT EXTRACT, SODIUM STEAROYL GLUTAMATE, TOCOPHERYL ACETATE, TRIETHANOLAMINE, PHENOXYETHANOL, WATER

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

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

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Standard Procedure.

SPF 50+ Sunscreen

Australian Made

Broad Spectrum UVA/UVB Rays

80 minutes Water Resistant


Advanced Ingredient Data


Raw Label Data

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