Carmex Classic Lip Balm Medicated Free Wintergreen Stick, Kit

Carmex Classic Lip Balm Medicated Free Wintergreen Stick, Kit
SPL v3
SPL
SPL Set ID bc0162bc-92ca-ee78-e053-2a95a90a7c9d
Route
TOPICAL
Published
Effective Date 2021-02-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (75 mg) Oxybenzone (40 mg) Camphor (synthetic) (17 mg) White Petrolatum (453 mg)
Inactive Ingredients
Petrolatum Lanolin Isopropyl Palmitate Ceresin Yellow Wax Cetyl Esters Wax Paraffin Meadowfoam Seed Oil Mineral Oil Menthol Salicylic Acid Phenol Vanillin

Identifiers & Packaging

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

Description

Octinoxate 7.50% Oxybenzone 4.00%

Purpose

External Analgesic Lip Protectant


Medication Information

Purpose

External Analgesic

Lip Protectant

Description

Octinoxate 7.50% Oxybenzone 4.00%

Uses

• helps protect against sunburn

• higher SPF gives more sunburn protection

Section 55105-1

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.

Directions

• apply liberally 15 minutes before sun exposure

• reapply: • after 80 minutes of swimming or sweating • immediately after towel drying

• at least every 2 hours

• children under 2 years of age: ask a doctor

Do Not Use On:

• deep puncture wounds • serious burns • animal bites

Active Ingredients

Octinoxate 7.50%

Oxybenzone 4.00%

Inactive Ingredients

petrolatum, lanolin, euphorbia cerifera (candelilla) wax, isopropyl palmitate, ozokerite, beeswax, cetyl esters, paraffin, theobroma cacao (cocoa) seed butter, flavor, limnanthes alba (meadowfoam) seed oil, stevia rebaudiana extract

When Using This Product:

keep out of eyes. Rinse with water to remove.

Package Labeling:10210 0033 1

Package Labeling:10210 0047 1

Package Labeling:10210 0038 0

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 protect against sunburn

• higher SPF gives more sunburn protection

Section 55105-1 (55105-1)

Purpose

External Analgesic

Lip Protectant

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.

Directions

• apply liberally 15 minutes before sun exposure

• reapply: • after 80 minutes of swimming or sweating • immediately after towel drying

• at least every 2 hours

• children under 2 years of age: ask a doctor

Do Not Use On: (Do not use on:)

• deep puncture wounds • serious burns • animal bites

Active Ingredients

Octinoxate 7.50%

Oxybenzone 4.00%

Inactive Ingredients

petrolatum, lanolin, euphorbia cerifera (candelilla) wax, isopropyl palmitate, ozokerite, beeswax, cetyl esters, paraffin, theobroma cacao (cocoa) seed butter, flavor, limnanthes alba (meadowfoam) 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 0033 1 (Package Labeling:10210-0033-1)

Package Labeling:10210 0047 1 (Package Labeling:10210-0047-1)

Package Labeling:10210 0038 0 (Package labeling:10210-0038-0)

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.


Advanced Ingredient Data


Raw Label Data

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