SPL v1
SPL
SPL Set ID 435748e6-c39a-efee-e063-6294a90ad0e5
Route
TOPICAL
Published
Effective Date 2025-11-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Octocrylene (7.5 g) Homosalate (10 g) Octisalate (5 g)
Inactive Ingredients
Glycerin Hyaluronic Acid Arachidyl Alcohol Water Tetrahexyldecyl Ascorbate Acetyl Hexapeptide-8 Alkyl (c12-15) Benzoate Tocopherol Caprylyl Glycol Bisabolol Xanthan Gum C15-19 Alkane Palmitoyl Pentapeptide-4 Tripeptide-29 Phenoxyethanol Behenyl Alcohol Glyceryl Stearate Citrate Arachidyl Glucoside

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-30

Description

For external use only Do not use on damaged or broken skin When using this product , keep out of the 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 Poison Control Center right away.

Purpose

Active Ingredients Purpose Homosalate 10%....................Sunscreen Octisalate 5%..........................Sunscreen Octocrylene 7.5%....................Sunscreen Avobenzone 3%.......................Sunscreen


Medication Information

Purpose

Active Ingredients Purpose

Homosalate 10%....................Sunscreen

Octisalate 5%..........................Sunscreen

Octocrylene 7.5%....................Sunscreen

Avobenzone 3%.......................Sunscreen

Dosage and Administration

  • For sunscreen use.
  • Apply generously and evenly 15 minutes before sun exposure.
  • Apply to all skin exposed to the sun
  • Reapply at least every 2 hours
  • Use a water-resistant sunscreen if swimming or sweating
  • Children under 6 years of age: Ask a doctor.
  • 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
Description

For external use only Do not use on damaged or broken skin When using this product , keep out of the 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 Poison Control Center right away.

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 51727-6

Water, C12-15 Alkyl Benzoate, Glyceryl Stearate Citrate, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Coco Caprylate, C15-19 Alkane, Glycerin, Bisabolol, Hyaluronic Acid, Tetrahexyldecyl Ascorbate (Vitamin C), Palmitoyl Pentapeptide-4, Acetyl Hexapeptide-8, Tripeptide-29, Vitamin B6, Tocopherol, Caprylyl Glycol, Xanthan Gum, Phenoxyethanol

Section 51945-4

www.gosolovegan.com

40mL | 1.35 fl.

Distributed by: YES SALES INC

1103 S BOYLE AVE LOS ANGELES, CA 90023 USA

www.gosolovegan.com

1-(800)-533-7403oz.

Section 60561-8

EXPIRATION DATE & LOT: On the product.

DATE D’EXPIRATION ET LOT: Sur le produit.

FECHA DE CADUCIDAD & LOTE: En el producto.

Warnings

  • For external use only
  • Do not use on damaged or broken skin
  • When using this product, keep out of the 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 Poison Control Center right away.

Keep Out of Reach of Children

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


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
Dosage and Administration (34068-7)

  • For sunscreen use.
  • Apply generously and evenly 15 minutes before sun exposure.
  • Apply to all skin exposed to the sun
  • Reapply at least every 2 hours
  • Use a water-resistant sunscreen if swimming or sweating
  • Children under 6 years of age: Ask a doctor.
  • 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
Section 51727-6 (51727-6)

Water, C12-15 Alkyl Benzoate, Glyceryl Stearate Citrate, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Coco Caprylate, C15-19 Alkane, Glycerin, Bisabolol, Hyaluronic Acid, Tetrahexyldecyl Ascorbate (Vitamin C), Palmitoyl Pentapeptide-4, Acetyl Hexapeptide-8, Tripeptide-29, Vitamin B6, Tocopherol, Caprylyl Glycol, Xanthan Gum, Phenoxyethanol

Section 51945-4 (51945-4)

www.gosolovegan.com

40mL | 1.35 fl.

Distributed by: YES SALES INC

1103 S BOYLE AVE LOS ANGELES, CA 90023 USA

www.gosolovegan.com

1-(800)-533-7403oz.

Section 60561-8 (60561-8)

EXPIRATION DATE & LOT: On the product.

DATE D’EXPIRATION ET LOT: Sur le produit.

FECHA DE CADUCIDAD & LOTE: En el producto.

Purpose

Active Ingredients Purpose

Homosalate 10%....................Sunscreen

Octisalate 5%..........................Sunscreen

Octocrylene 7.5%....................Sunscreen

Avobenzone 3%.......................Sunscreen

Warnings

  • For external use only
  • Do not use on damaged or broken skin
  • When using this product, keep out of the 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 Poison Control Center right away.

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

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


Advanced Ingredient Data


Raw Label Data

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