435748e6-c39a-efee-e063-6294a90ad0e5

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

Purpose

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

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.


Medication Information

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.

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

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.

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.

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

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.

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

Active Ingredients Purpose

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

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

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

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

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.

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

All Sections (JSON)