Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 72ee5f30-81cb-42d4-8165-951548a4fbb3
Route
TOPICAL
Published
Effective Date 2021-06-18
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 Isocetyl Stearate Lanolin Mineral Oil Paraffin Saccharin .alpha.-tocopherol Linoleate, D- .alpha.-tocopherol Acetate White Wax Arachidyl Propionate Camphor (natural) Isopropyl Myristate Lemon Oil Light Mineral Oil Maltol Octyldodecanol Phenyl Trimethicone D&c Red No. 6 Levomenthol Oleyl Alcohol Titanium Dioxide Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-06-28
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 if rash occurs

Section 50567-7

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

Section 50570-1

Do not use on 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
Active Ingredient

White petrolatum 45%

Other Information

store at 20-25°C (68-77°F)

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

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

Questions Or Comments?

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

Principal Display Panel

NDC 0573-2028-01

ChapStick®

PUT YOUR LIPS FIRST®

8 HOUR MOISTURE

SPF 15

  • •
    9 Classic Cherry/Skin Protectant
  • •
    9 Classic Original/Skin Protectant
  • •
    9 Classic Strawberry/Skin Protectant
  • •
    9 Moisturizer Original Skin/Sunscreen/Broad Spectrum SPF 15

NET WT 0.15 OZ

(4 g) EACH

36 INDIVIDUAL STICKS

PAA171900 – Front Carton

Inactive Ingredients (classic 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 (classic 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 dioxide, white wax, yellow 5 lake

Inactive Ingredients (classic 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 if rash occurs

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use on 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
Active Ingredient (Active ingredient)

White petrolatum 45%

Other Information

store at 20-25°C (68-77°F)

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

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

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 0573-2028-01

ChapStick®

PUT YOUR LIPS FIRST®

8 HOUR MOISTURE

SPF 15

  • •
    9 Classic Cherry/Skin Protectant
  • •
    9 Classic Original/Skin Protectant
  • •
    9 Classic Strawberry/Skin Protectant
  • •
    9 Moisturizer Original Skin/Sunscreen/Broad Spectrum SPF 15

NET WT 0.15 OZ

(4 g) EACH

36 INDIVIDUAL STICKS

PAA171900 – Front Carton

Inactive Ingredients (classic Cherry) (Inactive Ingredients (Classic 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 (classic Original) (Inactive ingredients (Classic 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 dioxide, white wax, yellow 5 lake

Inactive Ingredients (classic Strawberry) (Inactive Ingredients (Classic 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

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:59:36.470583 · Updated: 2026-03-14T22:59:41.656939