Lip Balm Spf15 Tropical Punch Flavored

Lip Balm Spf15 Tropical Punch Flavored
SPL v1
SPL
SPL Set ID 30e0c795-c388-287e-e063-6394a90aad25
Route
TOPICAL
Published
Effective Date 2025-03-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxybenzone (0.2 g) Octisalate (0.3 g)
Inactive Ingredients
Petrolatum Lecithin, Soybean Cetyl Esters Wax Cocos Nucifera (coconut) Oil Beeswax Euphorbia Cerifera (candelilla) Wax Fd&c Yellow No. 6 Aluminum Lake

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-21

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Drug Facts

Uses

Help prevent sunburn

Section 50566-9

if rash occurs

Section 50567-7

keep out of eyes. Rinse with water to remove.

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

Drug Facts

Drug Facts

Package Label Pdp

Lip Balm SPF15 Tropcial Punch flavored (NDC 72449-414-01)

Active Ingredients

Oxybenzone 4.7%

Octisalate 7.3%

Inactive Ingredients

Cocos Nucifera (Coconut Oil), Beeswax, Cetyl Esters Wax,

Petrolatum, Cerifera (Candelilla Wax), Flavor, Yellow 6 Lake, Soy Lecithin

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 2 pm

▪ Wear long sleeved shirts, pants, hats, and sunglasses

Keep Out of Reach of Children

If swallowed, get medical help or

contact a Poison Control Center right away


Structured Label Content

Uses

Help prevent sunburn

Section 50566-9 (50566-9)

if rash occurs

Section 50567-7 (50567-7)

keep out of eyes. Rinse with water to remove.

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

Drug Facts

Drug Facts

Package Label Pdp (Package Label PDP)

Lip Balm SPF15 Tropcial Punch flavored (NDC 72449-414-01)

Active Ingredients

Oxybenzone 4.7%

Octisalate 7.3%

Inactive Ingredients

Cocos Nucifera (Coconut Oil), Beeswax, Cetyl Esters Wax,

Petrolatum, Cerifera (Candelilla Wax), Flavor, Yellow 6 Lake, Soy Lecithin

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 2 pm

▪ Wear long sleeved shirts, pants, hats, and sunglasses

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

All Sections (JSON)