SPL v1
SPL
SPL Set ID 30cb27e9-d345-a5d1-e063-6394a90ad13a
Route
TOPICAL
Published
Effective Date 2025-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-20
Description

Drug Facts

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Drug Facts

Uses

Helps prevent sunburn

Section 42229-5

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

Section 51727-6

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

Petrolatum, Cerifera (Candelilla Wax), Flavor.

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 Pina Colada flavored (NDC 72449-406-01)

Active Ingredients

Oxybenzone 4.7%

Octisalate 7.3%

Questions Or Comments?

Call weekdays from 9AM to 5PM EST

at 631-231-2300

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

Section 42229-5 (42229-5)

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

Section 51727-6 (51727-6)

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

Petrolatum, Cerifera (Candelilla Wax), Flavor.

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 Pina Colada flavored (NDC 72449-406-01)

Active Ingredients

Oxybenzone 4.7%

Octisalate 7.3%

Questions Or Comments? (Questions or Comments?)

Call weekdays from 9AM to 5PM EST

at 631-231-2300

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

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:44.840787 · Updated: 2026-03-14T23:08:02.764471