SPL v3
SPL
SPL Set ID 0def5c19-b088-2ffb-e063-6394a90aa109
Route
TOPICAL
Published
Effective Date 2024-01-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (5 g) Homosalate (10 g) Avobenzone (3 g) Octocrylene
Inactive Ingredients
Glycerin Behenyl Alcohol Water Edetate Disodium Anhydrous Peg-20 Methyl Glucose Sesquistearate Cyclomethicone Carbomer Copolymer Type A Xanthan Gum Isopropyl Isostearate Sodium Hydroxide Phenoxyethanol Methyl Gluceth-20 Medium-chain Triglycerides Propylene Glycol Methyl Glucose Sesquistearate Zinc Oxide Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-01

Description

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

Purpose

Sunscreen Agent


Medication Information

Purpose

Sunscreen Agent

Dosage and Administration
  • apply liberally 15 minutes before sun exposure.
  • reapply after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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: Ask a doctor
Description

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

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 51945-4

Warnings

For external use only

• May stain some fabrics and surfaces.

Questions

www.drspharmacyusa.com

Do Not Use

on damaged or broken skin

Other Information

protect this product from excessive heat and direct sunlight

Active Ingredients

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

Inctive Ingredients

Water, Carbomer,capric/caprylic Triglyceride, Glycerin, Sodium Hydroxide, Propylene Glycol, Xanthan Gum, methyl glycose sesquistearate,PEG-20 methyl glycose sesquistearate, Cyclomethicone, Behenyl alcohol, Isopropyl isostearate, phenoxyethanol, Methyl Gluceth-20, Disodium EDTA.

When Using This Product

keep out of eyes. Rinse with water to remove it

Stop Use and Ask A Doctor

if rash occurs

Keep Out of Reach of Children

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


Structured Label Content

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.

Dosage and Administration (34068-7)
  • apply liberally 15 minutes before sun exposure.
  • reapply after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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: Ask a doctor
Section 51945-4 (51945-4)

Purpose (PURPOSE)

Sunscreen Agent

Warnings (WARNINGS)

For external use only

• May stain some fabrics and surfaces.

Questions

www.drspharmacyusa.com

Do Not Use (Do not use)

on damaged or broken skin

Other Information (other information)

protect this product from excessive heat and direct sunlight

Active Ingredients (ACTIVE INGREDIENTS)

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

Inctive Ingredients (Inctive ingredients)

Water, Carbomer,capric/caprylic Triglyceride, Glycerin, Sodium Hydroxide, Propylene Glycol, Xanthan Gum, methyl glycose sesquistearate,PEG-20 methyl glycose sesquistearate, Cyclomethicone, Behenyl alcohol, Isopropyl isostearate, phenoxyethanol, Methyl Gluceth-20, Disodium EDTA.

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove it

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs

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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