30c746ee-7d43-fd06-e063-6394a90ad3ac

SPL v1
SPL
SPL Set ID 30c746ee-7d43-fd06-e063-6394a90ad3ac
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
red 40 lake cocos nucifera (coconut) oil cetyl esters wax petrolatum euphorbia cerifera (candelilla) wax lecithin, soybean beeswax

Identifiers & Packaging

Pill Appearance
Color: red
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
Inactive Ingredients

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

Petrolatum, Cerifera (Candelilla Wax), Flavor, Red 40 Lake, Soy Lecithin

Description

Drug Facts

Section 50566-9

if rash occurs

Drug Facts

Drug Facts

Package Label Pdp

Lip Balm SPF15 Bubble Gum flavored (NDC 72449-402-01)

Active Ingredients

Oxybenzone 4.7%

Octisalate 7.3%

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

When Using This Product

keep out of eyes. Rinse with water to remove.

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
Inactive Ingredients

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

Petrolatum, Cerifera (Candelilla Wax), Flavor, Red 40 Lake, Soy Lecithin

Section 50566-9 (50566-9)

if rash occurs

Drug Facts

Drug Facts

Package Label Pdp (Package Label PDP)

Lip Balm SPF15 Bubble Gum flavored (NDC 72449-402-01)

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

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

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

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

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Source: dailymed · Ingested: 2026-02-15T12:05:44.837388 · Updated: 2026-03-14T23:08:02.764471