Natural Lip Balm Spf15 ( Passion Fruit Lb100fpft )

Natural Lip Balm Spf15 ( Passion Fruit Lb100fpft )
SPL v1
SPL
SPL Set ID 31544568-c556-72b2-e063-6294a90ace91
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
Bht Mineral Oil Beeswax Ethylhexyl Palmitate Ceresin Phenoxyethanol Fragrance 13576 Synthetic Wax (1800 Mw) Polyisobutylene (1000 Mw) Cocos Nucifera (coconut) Oil Olea Europaea Fruit Volatile Oil Butyrospermum Parkii (shea) Butter Yellow 5

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-27

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Warnings and Precautions

For external use only

Purpose

Sunscreen

Description

Drug Facts

Uses
  • Helps prevent sunburn
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

Section 60561-8

Sun Protection Measures

Spending time in the sun increases your risk of skin cancer and early skin aging.

To decreases 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.- 2p.m.

wear long-sleeve shirts, pants, hats and sunglasses

Warnings

For external use only

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

Octocrylene 3%

Homosalate 5%

Avobenzone 2%

Octisalate 3%

Inactive Ingredients

Mineral Oil, Beeswax, Ethylhexyl Palmitate, Ozokerite, Cocos Nucifera (Coconut) Oil,Olea Europaea (Olive) Fruit Oil,Polyisobutene, Butyrospermum Parkii (Shea) Butter, Synthetic Wax, Phenoxyethanol,Fragrance, Yellow 5 (Tartrazne), BHT

Questions Or Comments?

Call weekdays from 9AM to 5PM EST at 631-231-2300


Structured Label Content

Uses
  • Helps prevent sunburn
Warnings and Precautions (34071-1)

For external use only

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)

Section 60561-8 (60561-8)

Sun Protection Measures

Spending time in the sun increases your risk of skin cancer and early skin aging.

To decreases 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.- 2p.m.

wear long-sleeve shirts, pants, hats and sunglasses

Purpose

Sunscreen

Warnings

For external use only

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

Octocrylene 3%

Homosalate 5%

Avobenzone 2%

Octisalate 3%

Inactive Ingredients (Inactive ingredients)

Mineral Oil, Beeswax, Ethylhexyl Palmitate, Ozokerite, Cocos Nucifera (Coconut) Oil,Olea Europaea (Olive) Fruit Oil,Polyisobutene, Butyrospermum Parkii (Shea) Butter, Synthetic Wax, Phenoxyethanol,Fragrance, Yellow 5 (Tartrazne), BHT

Questions Or Comments? (Questions or Comments?)

Call weekdays from 9AM to 5PM EST at 631-231-2300


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)