sunscreen stick spf30 (cb400 )

sunscreen stick spf30 (cb400 )
SPL v1
SPL
SPL Set ID 316498d9-32fe-f884-e063-6394a90a4307
Route
topical
Published
Effective Date 2025-03-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octocrylene (10 g) homosalate (3 g) avobenzone (5 g) octisalate
Inactive Ingredients
bht mineral oil beeswax ceresin phenoxyethanol octyl palmitate fragrance 13576 microcrystalline wax polyisobutylene (1000 mw) butyrospermum parkii (shea) butter .alpha.-tocopherol acetate, dl- petrolatum

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-03-27
Purpose

Sunscreen

Description

Drug Facts

Medication Information

Warnings

For external use only.

Uses
  • Helps prevent sunburn
Purpose

Sunscreen

Directions
  • Apply liberally 15minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Children under 6 months of age: Ask a doctor.
Other Information

protect form excessive heat and direct sun.

Inactive Ingredients

Mineral Oil, Petrolatum, Ozokerite wax, Microcrystalline wax, Butyrospermum Parkii (Shea) Butter, Isooctyl palmitate, Polyisobutene, Beeswax, Phenoxyethanol, Tocopherol acetate, BHT, Fragrance

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 51945-4

Do Not Use

Do not use on damaged or broken skin.

Active Ingredients

Homosalate 10%

Octocrylene 10%

Octisalate 5%

Avobenzone 3%

When Using This Product

when using this product keep out of eyes, rinse with water to remove.

Structured Label Content

Warnings (warnings)

For external use only.

Uses
  • Helps prevent sunburn
Purpose

Sunscreen

Directions
  • Apply liberally 15minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Children under 6 months of age: Ask a doctor.
Other Information (other information)

protect form excessive heat and direct sun.

Inactive Ingredients (Inactive ingredients)

Mineral Oil, Petrolatum, Ozokerite wax, Microcrystalline wax, Butyrospermum Parkii (Shea) Butter, Isooctyl palmitate, Polyisobutene, Beeswax, Phenoxyethanol, Tocopherol acetate, BHT, Fragrance

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 51945-4 (51945-4)

Do Not Use (Do not use)

Do not use on damaged or broken skin.

Active Ingredients (Active ingredients)

Homosalate 10%

Octocrylene 10%

Octisalate 5%

Avobenzone 3%

When Using This Product (When using this product)

when using this product keep out of eyes, rinse with water to remove.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:48.385627 · Updated: 2026-03-14T23:08:08.103878