lip balm spf15 ( cb400)

lip balm spf15 ( cb400)
SPL v1
SPL
SPL Set ID 316463e0-dc1f-e2ae-e063-6394a90a0c3c
Route
topical
Published
Effective Date 2025-03-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octocrylene (8 g) octisalate (4 g)
Inactive Ingredients
petrolatum mineral oil beeswax ceresin phenoxyethanol fragrance 13576 microcrystalline wax polyisobutylene (1000 mw) tocopherol butyrospermum parkii (shea) butter

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 from excessive heat and direct sun.

Inactive Ingredients

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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If 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 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin.

Section 51945-4

Active Ingredients

Octocrylene 8%

Octisalate 4%

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 from excessive heat and direct sun.

Inactive Ingredients (Inactive ingredients)

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If 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 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Section 51945-4 (51945-4)

Active Ingredients (Active ingredients)

Octocrylene 8%

Octisalate 4%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:48.383805 · Updated: 2026-03-14T23:08:08.103878