Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID d1998a9e-d61f-4b4c-91b0-5e66754bcc4a
Route
TOPICAL
Published
Effective Date 2023-05-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (500 mg)
Inactive Ingredients
Aloe Vera Leaf Argan Oil Astrocaryum Murumuru Seed Butter Yellow Wax Shea Butter Medium-chain Triglycerides Safflower Oil Coconut Oil Carnauba Wax Candelilla Wax Sunflower Oil Hydrogenated Jojoba Oil/jojoba Oil, Randomized (iodine Value 57-61) Hydrogenated Jojoba Oil, Randomized Mangifera Indica Seed Butter Polyhydroxystearic Acid (2300 Mw) Tocopherol .alpha.-tocopherol Acetate .alpha.-bisabolol, (+/-)- Mangifera Indica Seed Safflower Castor Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-05-31

Description

Zinc Oxide 20.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 20.5%

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
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:

  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
Do Not Use
  • on damaged or broken skin
Active Ingredient

Zinc Oxide 20.5%

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

Paraben Free

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

For US Patent or Application status see www.productpats.com

200219

Questions Or Comments?

call weekdays from 8 AM to 6 PM at 1-800-245-1040

Principal Display Panel

ChapStick ®

NEW

BRAND LIP CARE

SUNSCREEN

BROAD SPECTRUM SPF 25

ACTIVE 2in1

mineral based SPF 25lock in moisture

VARIETY PACK

REEF FRIENDLY

FREE FROM

parabens

phthalates

preservatives

ALL WEATHER

3 STICKS

NET WT 0.18 OZ

(5 g) EACH

200219

When Using This Product
  • keep out of eyes. Rinse with water to remove.
Keep Out of Reach of Children.

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

Inactive Ingredients (unscented)

aloe barbadensis leaf extract, argania spinosa kernel oil, astrocaryum murumuru seed butter, beeswax,

bisabolol, butyrospermum parkii (shea) butter, caprylic/capric triglyceride, carthamus tinctorius

(safflower) seed oil, cocos nucifera (coconut) oil, copernicia cerifera (carnauba) wax, euphorbia

cerifera (candelilla) wax, helianthus annuus (sunflower) seed oil, jojoba esters, mangifera indica

(mango) seed butter, polyhydroxystearic acid, tocopherol, tocopheryl acetate

Inactive Ingredients (fresh Mint)

aloe barbadensis leaf extract, argania spinosa kernel oil, astrocaryum murumuru seed butter, beeswax,

bisabolol, butyrospermum parkii (shea) butter, caprylic/capric triglyceride, carthamus tinctorius (safflower) seed oil, cocos nucifera (coconut) oil, copernicia cerifera (carnauba) wax, euphorbia cerifera

(candelilla) wax, helianthus annuus (sunflower) seed oil, jojoba esters, mangifera indica (mango) seed

butter, natural flavors, polyhydroxystearic acid, tocopherol, tocopheryl acetate, yellow 6 lake

Inactive Ingredients (wild Berry)

aloe barbadensis leaf extract, argania spinosa kernel oil, astrocaryum murumuru seed butter, beeswax,

bisabolol, butyrospermum parkii (shea) butter, caprylic/capric triglyceride, carthamus tinctorius

(safflower) seed oil, cocos nucifera (coconut) oil, copernicia cerifera (carnauba) wax, euphorbia

cerifera (candelilla) wax, helianthus annuus (sunflower) seed oil, jojoba esters, mangifera indica

(mango) seed butter, natural flavors, polyhydroxystearic acid, ricinus communis (castor) seed oil,

tocopherol, tocopheryl acetate


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
Purpose

Sunscreen

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:

  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
Do Not Use (Do not use)
  • on damaged or broken skin
Active Ingredient (Active ingredient)

Zinc Oxide 20.5%

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

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

For US Patent or Application status see www.productpats.com

200219

Questions Or Comments? (Questions or comments?)

call weekdays from 8 AM to 6 PM at 1-800-245-1040

Principal Display Panel

ChapStick ®

NEW

BRAND LIP CARE

SUNSCREEN

BROAD SPECTRUM SPF 25

ACTIVE 2in1

mineral based SPF 25lock in moisture

VARIETY PACK

REEF FRIENDLY

FREE FROM

parabens

phthalates

preservatives

ALL WEATHER

3 STICKS

NET WT 0.18 OZ

(5 g) EACH

200219

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

Inactive Ingredients (unscented) (Inactive ingredients (Unscented))

aloe barbadensis leaf extract, argania spinosa kernel oil, astrocaryum murumuru seed butter, beeswax,

bisabolol, butyrospermum parkii (shea) butter, caprylic/capric triglyceride, carthamus tinctorius

(safflower) seed oil, cocos nucifera (coconut) oil, copernicia cerifera (carnauba) wax, euphorbia

cerifera (candelilla) wax, helianthus annuus (sunflower) seed oil, jojoba esters, mangifera indica

(mango) seed butter, polyhydroxystearic acid, tocopherol, tocopheryl acetate

Inactive Ingredients (fresh Mint) (Inactive ingredients (Fresh Mint))

aloe barbadensis leaf extract, argania spinosa kernel oil, astrocaryum murumuru seed butter, beeswax,

bisabolol, butyrospermum parkii (shea) butter, caprylic/capric triglyceride, carthamus tinctorius (safflower) seed oil, cocos nucifera (coconut) oil, copernicia cerifera (carnauba) wax, euphorbia cerifera

(candelilla) wax, helianthus annuus (sunflower) seed oil, jojoba esters, mangifera indica (mango) seed

butter, natural flavors, polyhydroxystearic acid, tocopherol, tocopheryl acetate, yellow 6 lake

Inactive Ingredients (wild Berry) (Inactive ingredients (Wild Berry))

aloe barbadensis leaf extract, argania spinosa kernel oil, astrocaryum murumuru seed butter, beeswax,

bisabolol, butyrospermum parkii (shea) butter, caprylic/capric triglyceride, carthamus tinctorius

(safflower) seed oil, cocos nucifera (coconut) oil, copernicia cerifera (carnauba) wax, euphorbia

cerifera (candelilla) wax, helianthus annuus (sunflower) seed oil, jojoba esters, mangifera indica

(mango) seed butter, natural flavors, polyhydroxystearic acid, ricinus communis (castor) seed oil,

tocopherol, tocopheryl acetate


Advanced Ingredient Data


Raw Label Data

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