30cb27e9-d345-a5d1-e063-6394a90ad13a

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

Purpose

Sunscreen

Description

Drug Facts

Medication Information

Warnings

For external use only

Do not Use on Damaged or Broken Skin

Uses

Helps prevent sunburn

Purpose

Sunscreen

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

Description

Drug Facts

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.

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

Warnings

For external use only

Do not Use on Damaged or Broken Skin

Uses

Helps prevent sunburn

Purpose

Sunscreen

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

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.

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

[{"name": "CETYL ESTERS WAX", "unii": "D072FFP9GU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCOS NUCIFERA (COCONUT) OIL", "unii": "Q9L0O73W7L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EUPHORBIA CERIFERA (CANDELILLA) WAX", "unii": "WL0328HX19", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OXYBENZONE", "unii": "95OOS7VE0Y", "classCode": "ACTIB", "strengthNumerator": "0.2", "strengthDenominator": "4.2", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "0.3", "strengthDenominator": "4.2", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "BEESWAX", "unii": "2ZA36H0S2V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Helps prevent sunburn", "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", "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": "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"}

Additional Information

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