lip balm spf15 ( cb222 )

SPL v1

SPL

SPL Set ID 316416d0-52b5-6f2f-e063-6294a90a9bc1

Route

topical

Published

Effective Date 2025-03-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

octocrylene (3 g) homosalate (5 g) avobenzone (2 g) octisalate

Inactive Ingredients

petrolatum tocopherol mineral oil ceresin fragrance 13576 microcrystalline wax polyisobutylene (1000 mw) butyrospermum parkii (shea) butter methylparaben propylparaben

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2025-03-27

Purpose

Sunscreen

Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

Uses

Helps prevent sunburn
helps prevent and temporarily protect dry, chapped or windblown lips.

Purpose

Sunscreen

Directions

Apply liberally before sun exposure and as needed.
Children under 6 months of age: Ask a doctor.

Inactive Ingredients

Microcrystalline wax, Ozokerite wax, Mineral Oil, Butyrospermum Parkii (Shea) Butter, Petrolatum, Polyisobutene, Methylparaben, Propylparaben, Tocopherol, 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 or irritation develops and persists

Section 51945-4

Section 53413-1

questions?

Section 60561-8

skin cancer/skin aging alert:

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn , not cancer or early aging.

Active Ingredients

Avobenzone 2%

Homosalate 5%

Octisalate 3%

Octocrylene 3%

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Uses

Helps prevent sunburn
helps prevent and temporarily protect dry, chapped or windblown lips.

Purpose

Sunscreen

Directions

Apply liberally before sun exposure and as needed.
Children under 6 months of age: Ask a doctor.

Inactive Ingredients (Inactive ingredients)

Microcrystalline wax, Ozokerite wax, Mineral Oil, Butyrospermum Parkii (Shea) Butter, Petrolatum, Polyisobutene, Methylparaben, Propylparaben, Tocopherol, 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 or irritation develops and persists

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

questions?

Section 60561-8 (60561-8)

skin cancer/skin aging alert:

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn , not cancer or early aging.

Active Ingredients (Active ingredients)

Avobenzone 2%

Homosalate 5%

Octisalate 3%

Octocrylene 3%

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "Helps prevent sunburn helps prevent and temporarily protect dry, chapped or windblown lips.", "34071-1": "Warnings", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if rash or irritation develops and persists", "53413-1": "questions?", "60561-8": "skin cancer/skin aging alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn , not cancer or early aging.", "Purpose": "Sunscreen", "Directions": "Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor.", "Active ingredients": "Avobenzone 2% Homosalate 5% Octisalate 3% Octocrylene 3%", "Inactive ingredients": "Microcrystalline wax, Ozokerite wax, Mineral Oil, Butyrospermum Parkii (Shea) Butter, Petrolatum, Polyisobutene, Methylparaben, Propylparaben, Tocopherol, Fragrance"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:48.381809 · Updated: 2026-03-14T23:08:08.103878