Lip Balm Spf15 Birthday Cake Flavored

Lip Balm Spf15 Birthday Cake Flavored
SPL v3
SPL
SPL Set ID f43429f8-d2cd-4ec8-a088-911d6d2248e5
Route
TOPICAL
Published
Effective Date 2025-03-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (0.31 g) Oxybenzone (0.2 g)
Inactive Ingredients
Cocos Nucifera (coconut) Oil Cetyl Esters Wax Petrolatum Euphorbia Cerifera (candelilla) Wax Beeswax

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-17

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Warnings and Precautions

For external use only

Do not Use on Damaged or Broken Skin

Purpose

Sunscreen

Description

Drug Facts

Uses

Helps prevent sunburn

Drug Fact

Drug Facts

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

LB100BDC Lip Balm SPF15 Birthday Cake (NDC 72440-403-01)

Active Ingredients

Oxybenzone 4.7%

Octisalate 7.3%

Inactive Ingredients

Cocos Nucifera (Coconut Oil), Beeswax, Cetyl Esters Wax, Petrolatum, Cerifera (Candelilla Wax), Flavor

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


Structured Label Content

Uses

Helps prevent sunburn

Warnings and Precautions (34071-1)

For external use only

Do not Use on Damaged or Broken Skin

Purpose

Sunscreen

Drug Fact

Drug Facts

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)

LB100BDC Lip Balm SPF15 Birthday Cake (NDC 72440-403-01)

Active Ingredients

Oxybenzone 4.7%

Octisalate 7.3%

Inactive Ingredients

Cocos Nucifera (Coconut Oil), Beeswax, Cetyl Esters Wax, Petrolatum, Cerifera (Candelilla Wax), Flavor

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


Advanced Ingredient Data


Raw Label Data

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