Spf15 Natural Lip Balm

Spf15 Natural Lip Balm
SPL v1
SPL
SPL Set ID 295f2a15-19fa-011f-e063-6394a90aea7b
Route
TOPICAL
Published
Effective Date 2024-12-16
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
Butyrospermum Parkii (shea) Butter Bht Mineral Oil Beeswax Ethylhexyl Palmitate Ceresin Phenoxyethanol Synthetic Wax (1800 Mw) Polyisobutylene (1000 Mw) Cocos Nucifera (coconut) Oil Olea Europaea Fruit Volatile Oil Fragrance 13576

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-16

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Warnings and Precautions

For external use only

Purpose

Sunscreen

Description

Drug Facts

Uses
  • Helps prevent sunburn
  • Higher SPF giwes more sunburn protection
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 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 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.
  • 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
Other Information

Protect this product from excessive heat and direct sun

Active Ingredients

Avobenzone 2%

Homosalate 5%

Octocrylene 3%

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, BHT


Structured Label Content

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

For external use only

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.
  • 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
Other Information (Other information)

Protect this product from excessive heat and direct sun

Active Ingredients (Active ingredients)

Avobenzone 2%

Homosalate 5%

Octocrylene 3%

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, BHT


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)