Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID bfb9a2d5-1ad2-45b8-a215-9d1370af5337
Route
TOPICAL
Published
Effective Date 2022-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (40 mg) Octisalate (45 mg) Octocrylene (26 mg) Petrolatum (384 mg)
Inactive Ingredients
Aloe Vera Leaf Isomethyl-.alpha.-ionone Anisyl Alcohol Benzyl Alcohol Benzyl Benzoate Benzyl Salicylate Butylated Hydroxytoluene Cetyl Alcohol Carnauba Wax Isocetyl Stearate Lanolin Mineral Oil Myristyl Alcohol Paraffin Stearyl Alcohol Tocopherol .alpha.-tocopherol Acetate White Wax Fd&c Blue No. 1 Aluminum Lake Medium-chain Triglycerides Isopropyl Titanium Triisostearate D&c Red No. 6 D&c Red No. 7 Aluminum Oxide Saccharin Synthetic Wax (1200 Mw) .alpha.-tocopherol Linoleate, D-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-01

Description

Avobenzone 3.0% Homosalate 4.0% Octisalate 4.5% Octocrylene 2.6% White Petrolatum 38.4%

Purpose

Sunscreens Skin protectant


Medication Information

Purpose

Sunscreens Skin protectant

Description

Avobenzone 3.0% Homosalate 4.0% Octisalate 4.5% Octocrylene 2.6% White Petrolatum 38.4%

Uses
  • helps prevent sunburn
  • helps prevent and temporarily protects chafed, chapped or cracked lips
  • helps prevent and protect from the drying effects of wind and cold weather
Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor ifrash occurs

Section 50567-7

When using this productkeep out of eyes. Rinse with water to remove.

Section 50570-1

Do not useon damaged or broken skin

Purposes

Sunscreens

Skin 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.

For external use only

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
Questions?

1-800-245-1040

Other Information
  • store at 20-25°C (68-77°F)
  • protect the product from excessive heat and direct sun
Additional Information

Paraben Free

Moisturizer

Variety Pack

Dist by: GSK CH, Warren, NJ 07059

For most recent product information,

visit www.chapstick.com

Trademarks owned or licensed by GSK.

©2022 GSK or licensor

Principal Display Panel

NEW

Formula

BRAND LIP CARE

ChapStick ®

SKIN PROTECTANT | SUNSCREEN

SPF 12

MOISTURIZER

2 in 1 Lipcare Variety Pack

8HOUR MOISTURE

SPF 12

3 STICKS

NET WT 0.15 OZ

(4 g) EACH

000073773

Active Ingredients (original)

Avobenzone 3.0%

Homosalate 4.0%

Octisalate 4.5%

Octocrylene 2.6%

White Petrolatum 38.4%

Active Ingredients (cool Mint)

Avobenzone 3.0%

Homosalate 4.0%

Octisalate 4.5%

Octocrylene 2.6%

White Petrolatum 36.9%

Inactive Ingredients (original)

aloe barbadensis leaf extract, alpha-isomethyl ionone, anise alcohol, benzyl alcohol, benzyl benzoate, benzyl salicylate, BHT, cetyl alcohol, copernicia cerifera (carnauba) wax, fragrance, isocetyl stearate, isopropyl lanolate, lanolin, mineral oil, myristyl alcohol, paraffin, stearyl alcohol, tocopherol, tocopheryl acetate, tocopheryl linoleate/oleate, white beeswax

Inactive Ingredients (cool Mint)

aloe barbadensis leaf extract, benzyl alcohol, BHT, cetyl alcohol, copernicia cerifera, (carnauba) wax, flavor, isocetyl stearate, isopropyl lanolate, lanolin, mineral oil, myristyl alcohol, paraffin, stearyl alcohol, tocopherol, tocopheryl acetate, tocopheryl linoleate/oleate, white beeswax

Active Ingredients (black Cherry)

Avobenzone 3.0%

Homosalate 4.0%

Octisalate 4.5%

Octocrylene 2.6%

White Petrolatum 36.8%

Inactive Ingredients (black Cherry)

aloe barbadensis leaf extract, BHT, blue 1 lake, caprylic/capric triglyceride, cetyl alcohol, copernicia cerifera (carnauba) wax, isocetyl stearate, isopropyl lanolate, isopropyl titanium triisostearate, lanolin, mineral oil, myristyl alcohol, natural flavor, paraffin, red 6 lake, red 7 lake, stearyl alcohol, synthetic wax,

tocopherol, tocopheryl acetate, tocopheryl linoleate/oleate, white beeswax


Structured Label Content

Uses
  • helps prevent sunburn
  • helps prevent and temporarily protects chafed, chapped or cracked lips
  • helps prevent and protect from the drying effects of wind and cold weather
Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor ifrash occurs

Section 50567-7 (50567-7)

When using this productkeep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not useon damaged or broken skin

Purposes

Sunscreens

Skin 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.

For external use only

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
Questions?

1-800-245-1040

Other Information (Other information)
  • store at 20-25°C (68-77°F)
  • protect the product from excessive heat and direct sun
Additional Information (Additional information)

Paraben Free

Moisturizer

Variety Pack

Dist by: GSK CH, Warren, NJ 07059

For most recent product information,

visit www.chapstick.com

Trademarks owned or licensed by GSK.

©2022 GSK or licensor

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NEW

Formula

BRAND LIP CARE

ChapStick ®

SKIN PROTECTANT | SUNSCREEN

SPF 12

MOISTURIZER

2 in 1 Lipcare Variety Pack

8HOUR MOISTURE

SPF 12

3 STICKS

NET WT 0.15 OZ

(4 g) EACH

000073773

Active Ingredients (original) (Active ingredients (Original))

Avobenzone 3.0%

Homosalate 4.0%

Octisalate 4.5%

Octocrylene 2.6%

White Petrolatum 38.4%

Active Ingredients (cool Mint) (Active ingredients (Cool Mint))

Avobenzone 3.0%

Homosalate 4.0%

Octisalate 4.5%

Octocrylene 2.6%

White Petrolatum 36.9%

Inactive Ingredients (original) (Inactive ingredients (Original))

aloe barbadensis leaf extract, alpha-isomethyl ionone, anise alcohol, benzyl alcohol, benzyl benzoate, benzyl salicylate, BHT, cetyl alcohol, copernicia cerifera (carnauba) wax, fragrance, isocetyl stearate, isopropyl lanolate, lanolin, mineral oil, myristyl alcohol, paraffin, stearyl alcohol, tocopherol, tocopheryl acetate, tocopheryl linoleate/oleate, white beeswax

Inactive Ingredients (cool Mint) (Inactive ingredients (Cool Mint))

aloe barbadensis leaf extract, benzyl alcohol, BHT, cetyl alcohol, copernicia cerifera, (carnauba) wax, flavor, isocetyl stearate, isopropyl lanolate, lanolin, mineral oil, myristyl alcohol, paraffin, stearyl alcohol, tocopherol, tocopheryl acetate, tocopheryl linoleate/oleate, white beeswax

Active Ingredients (black Cherry) (Active ingredients (Black Cherry))

Avobenzone 3.0%

Homosalate 4.0%

Octisalate 4.5%

Octocrylene 2.6%

White Petrolatum 36.8%

Inactive Ingredients (black Cherry) (Inactive ingredients (Black Cherry))

aloe barbadensis leaf extract, BHT, blue 1 lake, caprylic/capric triglyceride, cetyl alcohol, copernicia cerifera (carnauba) wax, isocetyl stearate, isopropyl lanolate, isopropyl titanium triisostearate, lanolin, mineral oil, myristyl alcohol, natural flavor, paraffin, red 6 lake, red 7 lake, stearyl alcohol, synthetic wax,

tocopherol, tocopheryl acetate, tocopheryl linoleate/oleate, white beeswax


Advanced Ingredient Data


Raw Label Data

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