drug facts

drug facts
SPL v1
SPL
SPL Set ID 50a73743-ca4b-471a-b337-ebf73a4b4ba4
Route
topical
Published
Effective Date 2013-08-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (3 g) homosalate (10 g) octisalate (5 g) octocrylene
Inactive Ingredients
water ethylhexyl palmitate sorbitol benzyl alcohol dimethicone glyceryl monostearate peg-100 stearate trolamine edetate disodium tocopherol aloe vera leaf chlorphenesin oleth-3 sodium ascorbyl phosphate

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2013-08-06
Purpose

Sunscreen

Description

Avobenzone   3.0% Homosalate   10.0% Octisalate       5.0% Octocrylene    10.0%

Medication Information

Warnings

For external use only. Do not use on damaged or broken skin.

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.
Purpose

Sunscreen

Directions
  • 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 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
  • children under 6 months of age: Ask a doctor
Other Information
  •  protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Ethylhexyl Palmitate, Sorbitol, Polyglyceryl-3 Methylglucose Distearate, Diethylhexyl Syringylidenemalonate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Glyceryl Stearate, PEG-100 Stearate, Caprylic/Capric Triglyceride, Disodium EDTA, Oleth-3, Tocopherol, Aloe Barbadensis Leaf Juice Powder, Sodium Ascorbyl Phosphate, Benzyl Alcohol, Chlorphenesin, Fragrance.

Description

Avobenzone   3.0% Homosalate   10.0% Octisalate       5.0% Octocrylene    10.0%

Principal Display Panel

exchange select

X

SUNSCREEN

lotion

30

BROAD SPECTRUM

SPF 30

UVA/UVB Protection

Water Resistant

(80 Minutes)

8 FL. OZ. (236 mL)







Active Ingredients

Avobenzone   3.0%

Homosalate   10.0%

Octisalate       5.0%

Octocrylene    10.0%

Questions Or Comments?

Call 1-386-673-2024



When Using This Product

Keep out of 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 a Poison Control Center right away. May stain some fabrics.

Structured Label Content

Warnings

For external use only. Do not use on damaged or broken skin.

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.
Purpose

Sunscreen

Directions
  • 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 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
  • children under 6 months of age: Ask a doctor
Other Information
  •  protect this product from excessive heat and direct sun

Inactive Ingredients (Inactive ingredients)

Water, Ethylhexyl Palmitate, Sorbitol, Polyglyceryl-3 Methylglucose Distearate, Diethylhexyl Syringylidenemalonate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Glyceryl Stearate, PEG-100 Stearate, Caprylic/Capric Triglyceride, Disodium EDTA, Oleth-3, Tocopherol, Aloe Barbadensis Leaf Juice Powder, Sodium Ascorbyl Phosphate, Benzyl Alcohol, Chlorphenesin, Fragrance.

Principal Display Panel

exchange select

X

SUNSCREEN

lotion

30

BROAD SPECTRUM

SPF 30

UVA/UVB Protection

Water Resistant

(80 Minutes)

8 FL. OZ. (236 mL)







Active Ingredients (Active ingredients)

Avobenzone   3.0%

Homosalate   10.0%

Octisalate       5.0%

Octocrylene    10.0%

Questions Or Comments? (Questions or comments?)

Call 1-386-673-2024



When Using This Product (When using this product)

Keep out of eyes. Rinse with water to remove.

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 swallowed, get medical help or contact a Poison Control Center right away. May stain some fabrics.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:40.959123 · Updated: 2026-03-14T22:53:34.467425