SPL v3
SPL
SPL Set ID baec9be7-5ae6-135c-e053-2995a90a2ed4
Route
TOPICAL
Published
Effective Date 2023-08-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (75 mg) Oxybenzone (40 mg)
Inactive Ingredients
Petrolatum Lanolin Isopropyl Palmitate Ceresin Yellow Wax Cetyl Esters Wax Paraffin Meadowfoam Seed Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-06-20

Description

Octinoxate 7.50% Oxybenzone 4.00%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 7.50% Oxybenzone 4.00%

Uses
  • helps protect against sunburn
  • higher SPF gives more sunburn protection
Warnings

 Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Skin Cancer/Skin Aging Alert:

For external use only

Directions
  • apply liberally 15 minutes before sun exposure
  • reapply: • at least every 2 hours
  • children under 2 years: Ask a doctor
Drug Facts

Do Not Use 

on damaged or broken skin

Other Information
  • this is a personal care item, and should be used by one individual only
  • protect this product from excessive heat and direct sun
  • do not use if safety seal is broken prior to purchase
Active Ingredients

Octinoxate 7.50%

Oxybenzone 4.00%

Inactive Ingredients

petrolatum, lanolin, euphorbia cerifera wax, isopropyl palmitate, ozokerite, beeswax, cetyl esters, paraffin, theobroma cacao seed butter, limnanthes alba seed oil, stevia rebaudiana extract

When Using This Product:

keep out of eyes. Rinse with water to remove.

Package Labeling:10210 0030 2

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.

Package Labeling: 10210 0030 1


Structured Label Content

Uses
  • helps protect against sunburn
  • higher SPF gives more sunburn protection
Purpose

Sunscreen

Warnings

 Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Skin Cancer/Skin Aging Alert:

For external use only

Directions
  • apply liberally 15 minutes before sun exposure
  • reapply: • at least every 2 hours
  • children under 2 years: Ask a doctor
Drug Facts

Do Not Use  (Do not use )

on damaged or broken skin

Other Information
  • this is a personal care item, and should be used by one individual only
  • protect this product from excessive heat and direct sun
  • do not use if safety seal is broken prior to purchase
Active Ingredients

Octinoxate 7.50%

Oxybenzone 4.00%

Inactive Ingredients

petrolatum, lanolin, euphorbia cerifera wax, isopropyl palmitate, ozokerite, beeswax, cetyl esters, paraffin, theobroma cacao seed butter, limnanthes alba seed oil, stevia rebaudiana extract

When Using This Product: (When using this product:)

keep out of eyes. Rinse with water to remove.

Package Labeling:10210 0030 2 (Package Labeling:10210-0030-2)

Stop Use and Ask A Doctor If: (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.

Package Labeling: 10210 0030 1 (Package Labeling: 10210-0030-1)


Advanced Ingredient Data


Raw Label Data

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