5326ae14-eb97-1351-e054-00144ff8d46c

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.
Active Ingredient

Ethylhexyl Methoxycinnamate, Octocrylene, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane

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

Structured Label Content

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.
Active Ingredient (55106-9)

Ethylhexyl Methoxycinnamate, Octocrylene, Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane

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



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

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