Lip Balm Spf15 Cherry

Lip Balm Spf15 Cherry
SPL v4
SPL
SPL Set ID 30a27c5f-912f-a7f5-e063-6294a90a0552
Route
TOPICAL
Published
Effective Date 2025-03-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (0.3 g) Oxybenzone (0.2 g)
Inactive Ingredients
Red 40 Lake Soybean Lecithin Cocos Nucifera (coconut) Oil Beeswax Cetyl Esters Wax Petrolatum Euphorbia Cerifera (candelilla) Wax

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-18

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Drug Facts

Uses

Helps prevent sunburn

Warnings

For external use only

Do not use on damaged or broken skin

Directions

  • Apply liberally 15 minutes 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
Package Label Pdp

LB100CA Label R1 NDC 72449-404-01

Active Ingredients

Oxybenzone 4.7%

Octisalate 7.3%

Inactive Ingredients

Cocos Nucifera (Coconut Oil), Beeswax, Cetyl Esters Wax, Petrolatum, Cerifera (Candelilla Wax), Flavor, Red 40 Lake, Soy Lecithin.

Lb100ca Lip Balm Spf15

Drug Facts

Questions Or Comments?

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

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 10am to 2pm
  • Wear long sleeved shirts, pants, hats, and sunglasses
When Using This Product

Keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor

if rash occurs

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away


Structured Label Content

Uses

Helps prevent sunburn

Purpose

Sunscreen

Warnings

For external use only

Do not use on damaged or broken skin

Directions

  • Apply liberally 15 minutes 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
Package Label Pdp (Package Label PDP)

LB100CA Label R1 NDC 72449-404-01

Active Ingredients

Oxybenzone 4.7%

Octisalate 7.3%

Inactive Ingredients

Cocos Nucifera (Coconut Oil), Beeswax, Cetyl Esters Wax, Petrolatum, Cerifera (Candelilla Wax), Flavor, Red 40 Lake, Soy Lecithin.

Lb100ca Lip Balm Spf15 (LB100CA Lip Balm SPF15)

Drug Facts

Questions Or Comments? (Questions or Comments?)

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

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 10am to 2pm
  • Wear long sleeved shirts, pants, hats, and sunglasses
When Using This Product (When using this product)

Keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop Use and Ask a Doctor)

if rash occurs

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away


Advanced Ingredient Data


Raw Label Data

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