Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 0e34fc74-772e-48fd-a353-58807ef412c1
Routes
TOPICAL ORAL
Published
Effective Date 2022-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Octinoxate (75 mg) Petrolatum (423 mg)
Inactive Ingredients
Aloe Vera Leaf Carnauba Wax Cetyl Alcohol .alpha.-tocopherol Linoleate, D- Isocetyl Stearate Lanolin Mineral Oil Paraffin Saccharin .alpha.-tocopherol Acetate White Wax Arachidyl Propionate Camphor (natural) Isopropyl Myristate Lemon Oil, Cold Pressed Light Mineral Oil Maltol Octyldodecanol Phenyl Trimethicone D&c Red No. 6 Levomenthol Oleyl Alcohol Titanium Dioxide Fd&c Yellow No. 5

Identifiers & Packaging

Pill Appearance
Shape: bullet Color: yellow Color: red Color: pink Size: 42 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-28

Description

Avobenzone 3% Octinoxate 7.5% White petrolatum 42.3%

Purpose

Sunscreens Skin protectant


Medication Information

Purpose

Skin protectant

Description

Avobenzone 3% Octinoxate 7.5% White petrolatum 42.3%

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
  • 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

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
  • 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:
    • limited time in the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
Ingredients:

helianthus annuus (sunflower) seed oil, jojoba esters, euphorbia cerifera (candelilla) wax, cocos nucifera (coconut) oil, beeswax, caprylic/capric triglyceride, copernicia cerifera (carnauba) wax,

argania spinosa (argan) kernel oil, flavor, tocopheryl acetate, carthamus tinctorius (safflower) seed oil, mangifera indica (mango) seed butter, butyrospermum parkii (shea) butter, octyldodecanol, persea gratissima (avocado) oil, olea europaea (olive) fruit oil, tocopherol, hydrogenated soybean oil, aloe barbadensis leaf extract, rubus idaeus (raspberry) seed oil, glyceryl stearate

Active Ingredient

White petrolatum 45%

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

store at 20-25°C (68-77°F).

Active Ingredients

Avobenzone 3%

Octinoxate 7.5%

White petrolatum 42.3%

Inactive Ingredients

aloe barbadensis leaf extract, carnauba wax, cetyl alcohol, fragrance, isocetyl stearate, isopropyl lanolate, lanolin, mineral oil, paraffin, saccharin, tocopheryl linoleate/oleate, vitamin E acetate, white wax

Additional Information

Paraben Free . Cruelty Free

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

For most recent product information, visit www.chapstick.com

Trademarks owned or licensed by GSK ©2021 GSK or licensor

Patents: www.productspats.com

Questions Or Comments?

call weekdays from 9 AM to 5 PM EST at 1-877-227-3421

Principal Display Panel

NDC 0573-2027-01

ChapStick ®

PUT YOUR LIPS FIRST®

1 EUCALYPTUS MINT

1 SOOTHING VANILLA

  • *100% naturally sourced ingredients
  • Age defying formula with argan oil and avocado butters
  • Contains omegas 6 & 9

2 MOISTURIZER ORIGINAL

SKIN PROTECTANT / SUNSCREEN

BROAD SPECTRUM SPF 15

SPF 15

2 CLASSIC STRAWBERRY

SKIN PROTECTANT

3 CLASSIC CHERRY

SKIN PROTECTANT

Paraben Free

Cruelty Free

3 CLASSIC ORIGINAL

SKIN PROTECTANT

12 INDIVIDUAL STICKS

TOTAL HYDRATION

-2 STICKS

NET WT 0.12 OZ

(3.5g) EACH

MOISTURIZER

-2 STICKS

NET WT 0.15 OZ

(4g) EACH

CLASSIC

-8 STICKS

NET WT 0.15 OZ

(4g) EACH

PAA166168 – Front

Inactive Ingredients (cherry)

arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, menthol, octyldodecanol, paraffin, phenyl trimethicone, red 6 lake, saccharin, white wax

Inactive Ingredients (original)

arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, octyldodecanol, oleyl alcohol, paraffin, phenyl trimethicone, red 6 lake, titanium, white wax, yellow 5 lake

Inactive Ingredients (strawberry)

arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, lemon oil, light mineral oil, maltol, octyldodecanol, paraffin, phenyl trimethicone, red 6 lake, saccharin, white wax


Structured Label Content

Uses
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
  • 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

Purpose

Skin protectant

Purposes

Sunscreens

Skin protectant

Warnings

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
  • 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:
    • limited time in the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
Ingredients:

helianthus annuus (sunflower) seed oil, jojoba esters, euphorbia cerifera (candelilla) wax, cocos nucifera (coconut) oil, beeswax, caprylic/capric triglyceride, copernicia cerifera (carnauba) wax,

argania spinosa (argan) kernel oil, flavor, tocopheryl acetate, carthamus tinctorius (safflower) seed oil, mangifera indica (mango) seed butter, butyrospermum parkii (shea) butter, octyldodecanol, persea gratissima (avocado) oil, olea europaea (olive) fruit oil, tocopherol, hydrogenated soybean oil, aloe barbadensis leaf extract, rubus idaeus (raspberry) seed oil, glyceryl stearate

Active Ingredient (Active ingredient)

White petrolatum 45%

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

store at 20-25°C (68-77°F).

Active Ingredients (Active ingredients)

Avobenzone 3%

Octinoxate 7.5%

White petrolatum 42.3%

Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf extract, carnauba wax, cetyl alcohol, fragrance, isocetyl stearate, isopropyl lanolate, lanolin, mineral oil, paraffin, saccharin, tocopheryl linoleate/oleate, vitamin E acetate, white wax

Additional Information

Paraben Free . Cruelty Free

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

For most recent product information, visit www.chapstick.com

Trademarks owned or licensed by GSK ©2021 GSK or licensor

Patents: www.productspats.com

Questions Or Comments? (Questions or Comments?)

call weekdays from 9 AM to 5 PM EST at 1-877-227-3421

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 0573-2027-01

ChapStick ®

PUT YOUR LIPS FIRST®

1 EUCALYPTUS MINT

1 SOOTHING VANILLA

  • *100% naturally sourced ingredients
  • Age defying formula with argan oil and avocado butters
  • Contains omegas 6 & 9

2 MOISTURIZER ORIGINAL

SKIN PROTECTANT / SUNSCREEN

BROAD SPECTRUM SPF 15

SPF 15

2 CLASSIC STRAWBERRY

SKIN PROTECTANT

3 CLASSIC CHERRY

SKIN PROTECTANT

Paraben Free

Cruelty Free

3 CLASSIC ORIGINAL

SKIN PROTECTANT

12 INDIVIDUAL STICKS

TOTAL HYDRATION

-2 STICKS

NET WT 0.12 OZ

(3.5g) EACH

MOISTURIZER

-2 STICKS

NET WT 0.15 OZ

(4g) EACH

CLASSIC

-8 STICKS

NET WT 0.15 OZ

(4g) EACH

PAA166168 – Front

Inactive Ingredients (cherry) (Inactive ingredients (Cherry))

arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, menthol, octyldodecanol, paraffin, phenyl trimethicone, red 6 lake, saccharin, white wax

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

arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, octyldodecanol, oleyl alcohol, paraffin, phenyl trimethicone, red 6 lake, titanium, white wax, yellow 5 lake

Inactive Ingredients (strawberry) (Inactive ingredients (Strawberry))

arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, lemon oil, light mineral oil, maltol, octyldodecanol, paraffin, phenyl trimethicone, red 6 lake, saccharin, white wax


Advanced Ingredient Data


Raw Label Data

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