SPL v1
SPL
SPL Set ID 5326ae14-eb97-1351-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2017-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7 g) Octocrylene (5 g) Octisalate (4.5 g) Avobenzone (4 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-06-30
Description

Ethylhexyl Methoxycinnamate, Octocrylene, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane

Medication Information

Warnings and Precautions
  • For external use only.
  • Do not use on damaged or broken skin.
  • 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.
  • do not place this product in this container in the excessive heat and direct sun.
Indications and Usage

apply generously 15 minutes before sun sxposure

reapply:

  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every two hours

Sun Protection Measures. Spending thime 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, expecially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses

children under 6 months of age: Ask a doctor

Dosage and Administration

for external use only



Description

Ethylhexyl Methoxycinnamate, Octocrylene, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane

Section 50565-1

keep out or reach of the children

Section 51727-6

Water, Butylene Glycol, etc

Section 51945-4

Section 55105-1
  • Suncreen
  • protects skin from UV rays
  • 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 55106-9

Ethylhexyl Methoxycinnamate, Octocrylene, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane

Structured Label Content

Indications and Usage (34067-9)

apply generously 15 minutes before sun sxposure

reapply:

  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every two hours

Sun Protection Measures. Spending thime 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, expecially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses

children under 6 months of age: Ask a doctor

Dosage and Administration (34068-7)

for external use only



Warnings and Precautions (34071-1)
  • For external use only.
  • Do not use on damaged or broken skin.
  • 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.
  • do not place this product in this container in the excessive heat and direct sun.
Section 50565-1 (50565-1)

keep out or reach of the children

Section 51727-6 (51727-6)

Water, Butylene Glycol, etc

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)
  • Suncreen
  • protects skin from UV rays
  • 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 55106-9 (55106-9)

Ethylhexyl Methoxycinnamate, Octocrylene, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:22.902718 · Updated: 2026-03-14T22:54:47.454101