092 Curad Petroleum-free Lip Balm

092 Curad Petroleum-free Lip Balm
SPL v8
SPL
SPL Set ID 6125d98a-6fc7-4f50-924e-3b1f7ee951f4
Route
TOPICAL
Published
Effective Date 2022-04-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (2 g) Oxybenzone (4.5 g)
Inactive Ingredients
Yellow Wax Sunflower Oil Castor Oil Lanolin Coconut Oil Corn Oil Butylated Hydroxytoluene Alpha-tocopherol Acetate Tea Tree Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-04-01

Description

Octinoxate 2.0% Oxybenzone 4.5%

Purpose

Sunscreen Sunscreen


Medication Information

Purpose

Sunscreen

Sunscreen

Description

Octinoxate 2.0% Oxybenzone 4.5%

Use
  • helps protect against sunburn and chapped lips
Section 43683-2
  • Indications and Usage
Warnings
  • Skin Cancer/Skin Aging Alert: 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.
  • For external use only.
Directions
  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: ask a doctor
Do Not Use

on damaged or broken skin.

Package Label

Other Information
  • protect this product from excessive heat and direct sun
  • to report a suspected adverse reaction, contact Curad.
Active Ingredients

Octinoxate 2.0%

Oxybenzone 4.5%

Inactive Ingredients

beeswax, BHT, cocos nucifera (coconut) oil, flavor, helianthus annuus (sunflower) seed oil, lanolin, melaleuca alternifolia (tea tree) leaf oil, ricinus communis (castor) seed oil, tocopheryl acetate, zea mays (corn) oil.

When Using This Product
  • keep out of eyes. Rinse with water to remove
Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA of foreign and domestic materials

www.curad.com

1-800-633-5463

REF: CUR0415

V1 RD22OLB

Stop Use and Ask A Doctor If
  • rash or irritation develops and lasts
Keep Out of Reach of Children.

If swallowed, get medical help of contact a Poison Control Center right away.


Structured Label Content

Use
  • helps protect against sunburn and chapped lips
Section 43683-2 (43683-2)
  • Indications and Usage
Purpose

Sunscreen

Sunscreen

Warnings
  • Skin Cancer/Skin Aging Alert: 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.
  • For external use only.
Directions
  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months: ask a doctor
Do Not Use (Do not use)

on damaged or broken skin.

Package Label

Other Information
  • protect this product from excessive heat and direct sun
  • to report a suspected adverse reaction, contact Curad.
Active Ingredients (Active ingredients)

Octinoxate 2.0%

Oxybenzone 4.5%

Inactive Ingredients (Inactive ingredients)

beeswax, BHT, cocos nucifera (coconut) oil, flavor, helianthus annuus (sunflower) seed oil, lanolin, melaleuca alternifolia (tea tree) leaf oil, ricinus communis (castor) seed oil, tocopheryl acetate, zea mays (corn) oil.

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove
Manufacturing Information

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA of foreign and domestic materials

www.curad.com

1-800-633-5463

REF: CUR0415

V1 RD22OLB

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash or irritation develops and lasts
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help of contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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