spf15 sunscreen

spf15 sunscreen
SPL v6
SPL
SPL Set ID 68035415-47c3-4eed-93f4-bb6b26c9149a
Route
topical
Published
Effective Date 2018-09-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (20 mg) homosalate (80 mg) octocrylene (55 mg) octisalate
Inactive Ingredients
mineral oil yellow wax coconut oil ethylhexyl palmitate high density polyethylene tridecyl trimellitate shea butter butylated hydroxytoluene methyl salicylate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2018-10-01
Purpose

Sunscreen

Description

Homosalate 8% Octocrylene 5.5% Avobenzone 2% Octisalate 2%

Medication Information

Warnings

For external use only.

Uses
  • Helps prevent sunburn
Purpose

Sunscreen

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Children under 6 months: Ask a doctor.
Other Information
  • Protect from excessive heat and direct sun.
Description

Homosalate 8% Octocrylene 5.5% Avobenzone 2% Octisalate 2%

Do Not Use

on damaged or broken skin.

Package Labeling:

Active Ingredients

Homosalate 8% Octocrylene 5.5% Avobenzone 2% Octisalate 2%





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

(sunscreen) Inactive Ingredients 

Mineral Oil, Beeswax, Ozokerite, Cera Microcristallina, Cocos Nucifera (Coconut) Oil, Ethylhexyl Palmitate, Ethylhexyl Palmitate, Polyisobutene, Polyethylene, Tridecyl Trimellitate, Butyrospermum Parkii (Shea Butter), BHT, Tocopheryl Acetate,Flavor. May Contain: Blue 1 Lake (CI 42090), Yellow 5 Lake(CI 19140), Yellow 6 Lake (CI 15985), Titanium Dioxide (CI 77891), Red 6 Lake (CI 15850), Red 7 Lake (CI 15850), Red 27 Lake (CI 45410), Red 28 Lake (CI 45410), Red 30 Lake (CI 73360), Iron Oxides (CI 77492, CI 77491, CI 77499).



Structured Label Content

Warnings

For external use only.

Uses
  • Helps prevent sunburn
Purpose

Sunscreen

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Children under 6 months: Ask a doctor.
Other Information
  • Protect from excessive heat and direct sun.
Do Not Use (Do not use)

on damaged or broken skin.

Package Labeling:

Active Ingredients

Homosalate 8% Octocrylene 5.5% Avobenzone 2% Octisalate 2%





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

(sunscreen) Inactive Ingredients  ((Sunscreen) Inactive Ingredients )

Mineral Oil, Beeswax, Ozokerite, Cera Microcristallina, Cocos Nucifera (Coconut) Oil, Ethylhexyl Palmitate, Ethylhexyl Palmitate, Polyisobutene, Polyethylene, Tridecyl Trimellitate, Butyrospermum Parkii (Shea Butter), BHT, Tocopheryl Acetate,Flavor. May Contain: Blue 1 Lake (CI 42090), Yellow 5 Lake(CI 19140), Yellow 6 Lake (CI 15985), Titanium Dioxide (CI 77891), Red 6 Lake (CI 15850), Red 7 Lake (CI 15850), Red 27 Lake (CI 45410), Red 28 Lake (CI 45410), Red 30 Lake (CI 73360), Iron Oxides (CI 77492, CI 77491, CI 77499).



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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:16.655329 · Updated: 2026-03-14T23:01:42.949822