Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 59023150-65ef-4427-9045-0e64b100cbab
Route
TOPICAL
Published
Effective Date 2021-03-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (101 mg)
Inactive Ingredients
Castor Oil Hydrogenated Jojoba Oil/jojoba Oil, Randomized (iodine Value 57-61) Hydrogenated Jojoba Oil/jojoba Oil, Randomized (iodine Value 40-44) Candelilla Wax Yellow Wax Lecithin, Sunflower Coconut Oil Mica Shea Butter Jojoba Oil Carnauba Wax .alpha.-tocopherol Acetate Carminic Acid Argan Oil Ferric Oxide Red Titanium Dioxide Tocopherol Levomenol Polyhydroxystearic Acid (2300 Mw)

Identifiers & Packaging

Pill Appearance
Shape: bullet Color: brown Color: purple
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-02-25

Description

Active ingredient Zinc Oxide 10.1%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

  • helps prevent sunburn
  • helps prevent and temporarily protects chafed, chapped or cracked lips
Dosage and Administration

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • children under 6 months of age: Ask a doctor
Description

Active ingredient Zinc Oxide 10.1%

Section 44425-7

Other information

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

Section 51727-6

Inactive ingredients

ricinus communis (castor) seed oil, jojoba esters, euphorbia cerifera (candelilla) wax, beeswax, lecithin (sunflower), cocos nucifera (coconut) oil, mica, fragrance, butyrospermum parkii (shea) butter, simmondsia chinensis (jojoba) seed oil, copernicia cerifera (carnauba) wax, tocopheryl acetate, carmine, argania spinosa kernel oil, iron oxides, titanium dioxide, tocopherol, bisabolol, polyhydroxystearic acid

Section 53413-1

Questions?

1-877-227-3421

Section 55105-1

Purpose

Skin Protectant/Sunscreen

Section 55106-9

Active ingredient

Zinc Oxide 10.1%

Principal Display Panel 2.2 G Cylinder Carton

ChapStick®

total hydration

LIP BALM SUNSCREEN

VERY

BERRY

Moisture

+ Tint

Broad

Spectrum

SPF 15

NET WT 0.08 OZ (2.2 g)

Principal Display Panel 2.2 G Cylinder Blister Pack

ChapStick®

total hydration

LIP BALM SUNSCREEN

Moisture

+ Tint

SPF 15

Natural

Sunscreen

Broad

Spectrum

SPF 15

Hydrates

+

Protects

100%

Naturally

Sourced

Ingredients

Very

Berry

NET WT

0.08 OZ

(2.2 g)


Structured Label Content

Indications and Usage (34067-9)

Uses

  • helps prevent sunburn
  • helps prevent and temporarily protects chafed, chapped or cracked lips
Dosage and Administration (34068-7)

Directions

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • children under 6 months of age: Ask a doctor
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

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

Section 51727-6 (51727-6)

Inactive ingredients

ricinus communis (castor) seed oil, jojoba esters, euphorbia cerifera (candelilla) wax, beeswax, lecithin (sunflower), cocos nucifera (coconut) oil, mica, fragrance, butyrospermum parkii (shea) butter, simmondsia chinensis (jojoba) seed oil, copernicia cerifera (carnauba) wax, tocopheryl acetate, carmine, argania spinosa kernel oil, iron oxides, titanium dioxide, tocopherol, bisabolol, polyhydroxystearic acid

Section 53413-1 (53413-1)

Questions?

1-877-227-3421

Section 55105-1 (55105-1)

Purpose

Skin Protectant/Sunscreen

Section 55106-9 (55106-9)

Active ingredient

Zinc Oxide 10.1%

Principal Display Panel 2.2 G Cylinder Carton (PRINCIPAL DISPLAY PANEL - 2.2 g Cylinder Carton)

ChapStick®

total hydration

LIP BALM SUNSCREEN

VERY

BERRY

Moisture

+ Tint

Broad

Spectrum

SPF 15

NET WT 0.08 OZ (2.2 g)

Principal Display Panel 2.2 G Cylinder Blister Pack (PRINCIPAL DISPLAY PANEL - 2.2 g Cylinder Blister Pack)

ChapStick®

total hydration

LIP BALM SUNSCREEN

Moisture

+ Tint

SPF 15

Natural

Sunscreen

Broad

Spectrum

SPF 15

Hydrates

+

Protects

100%

Naturally

Sourced

Ingredients

Very

Berry

NET WT

0.08 OZ

(2.2 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)