Sunscreen Spf15 Scent Lip Balm

Sunscreen Spf15 Scent Lip Balm
SPL v1
SPL
SPL Set ID 20e122e2-09ad-63ad-e063-6294a90a83fc
Route
TOPICAL
Published
Effective Date 2022-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (8 g) Octisalate (4 g)
Inactive Ingredients
Fragrance 13576 Polyisobutylene (1000 Mw) Ethylhexyl Palmitate Mineral Oil Petrolatum Yellow Wax Shea Butter Microcrystalline Wax Phenoxyethanol .alpha.-tocopherol Acetate, D- Ceresin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-01
Description

Octocrylene 8% Octisalate 4%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Octocrylene 8% Octisalate 4%

Uses
  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection
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 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

Warnings

For external use only.

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
  • Sun protection Measures

Spending time 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, especially from 10a.m.- 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses
Other Information

Protect from excessive heat and direct sun.

Active Ingredients

Octocrylene 8%

Octisalate 4%

Inactive Ingredients

Paraffinum liquidum, Petrolatum, Ozokerite, Polyisobutene, Ethylhexyl Palmitate, Beeswax, Butyrospermum Parkii (Shea) Butter, Microcrystalline Wax, Phenoxyethanol, Fragrance, Tocopheryl Acetate

Structured Label Content

Uses
  • Helps prevent sunburn
  • Higher SPF gives more sunburn protection
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 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)

Purpose

Sunscreen

Warnings (warnings)

For external use only.

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
  • Sun protection Measures

Spending time 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, especially from 10a.m.- 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses
Other Information (Other information)

Protect from excessive heat and direct sun.

Active Ingredients

Octocrylene 8%

Octisalate 4%

Inactive Ingredients

Paraffinum liquidum, Petrolatum, Ozokerite, Polyisobutene, Ethylhexyl Palmitate, Beeswax, Butyrospermum Parkii (Shea) Butter, Microcrystalline Wax, Phenoxyethanol, Fragrance, Tocopheryl Acetate

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:30.391667 · Updated: 2026-03-14T23:03:35.185430