SPL v1
SPL
SPL Set ID 30df181f-2dda-90ea-e063-6394a90a2f69
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
Red 40 Lake Beeswax Titanium Dioxide Lecithin, Soybean Petrolatum Cocos Nucifera (coconut) Oil Euphorbia Cerifera (candelilla) Wax Cetyl Esters Wax

Identifiers & Packaging

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

Drug Facts

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Drug Facts

Uses

Helps prevent sunburn

Section 50567-7

keep out of eyes. Rinse with water to remove.

Section 51727-6

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

Petrolatum, Cerifera (Candelilla Wax), Flavor, Titanium Dioxide, Red 40 Lake,

Soy Lecithin

Section 51945-4

Lip Balm SPF15 Strawberry Shortcake flavored (NDC 72449-412-01)

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

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

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 50567-7 (50567-7)

keep out of eyes. Rinse with water to remove.

Section 51727-6 (51727-6)

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

Petrolatum, Cerifera (Candelilla Wax), Flavor, Titanium Dioxide, Red 40 Lake,

Soy Lecithin

Section 51945-4 (51945-4)

Lip Balm SPF15 Strawberry Shortcake flavored (NDC 72449-412-01)

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

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

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

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Source: dailymed · Ingested: 2026-02-15T12:05:46.011368 · Updated: 2026-03-14T23:08:02.764471