Spit & Polish Mineral Lip Balm, Broad Spectrum Lip Protectant, Spf 30

Spit & Polish Mineral Lip Balm, Broad Spectrum Lip Protectant, Spf 30
SPL v2
SPL
SPL Set ID af882b7e-c64f-0de6-e053-2995a90a7ca0
Route
TOPICAL
Published
Effective Date 2020-09-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (80 mg)
Inactive Ingredients
Almond Shea Butter Yellow Wax Jojoba Oil Candelilla Wax .alpha.-tocopherol Acetate, Dl- Argan Oil Carnauba Wax Levomenol Glyceryl Monocaprylate Glyceryl 1-undecylenate Triethoxycaprylylsilane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-01

Description

Zinc Oxide 8%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 8%

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.

Drug Facts

Do Not Use
  • on damaged or broken skin.
  • If rash occurs,
Directions:
  • Apply liberally 15 minutes before sun exposure.
  • Reapply:
  • After 80 minutes of swimming or sweating.
  • Immediately after towel drying.
  • At least every 2 hours.

Sun protection measures

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures.

Package Labeling:

Active Ingredients

Zinc Oxide 8%

Inactive Ingredients:

Prunus Amygdalus Dulcis (Almond) Oil, Butyrospermum Parkii (Shea) Butter, Cera Alba (Beeswax), Simmondsia Chinensis (Jojoba) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, DL-Alpha-Tocopheryl Acetate, Argania Spinosa Kernel (Argan) Oil, Copernicia Cerifera (Carnauba) Wax, Bisabolol, Glyceryl Caprylate, Glyceryl Undecylenate, Triethoxycaprylylsilane

Keep Out of Reach of Children.
  • If product is swallowed, get medical help or contact a Poison Control Center right away.
Stop Use and Consult A Doctor.


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.

Drug Facts (DRUG FACTS)

Do Not Use (Do not use)
  • on damaged or broken skin.
  • If rash occurs,
Directions:
  • Apply liberally 15 minutes before sun exposure.
  • Reapply:
  • After 80 minutes of swimming or sweating.
  • Immediately after towel drying.
  • At least every 2 hours.

Sun protection measures

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures.

Package Labeling:

Active Ingredients

Zinc Oxide 8%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Prunus Amygdalus Dulcis (Almond) Oil, Butyrospermum Parkii (Shea) Butter, Cera Alba (Beeswax), Simmondsia Chinensis (Jojoba) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, DL-Alpha-Tocopheryl Acetate, Argania Spinosa Kernel (Argan) Oil, Copernicia Cerifera (Carnauba) Wax, Bisabolol, Glyceryl Caprylate, Glyceryl Undecylenate, Triethoxycaprylylsilane

Keep Out of Reach of Children. (Keep out of reach of children.)
  • If product is swallowed, get medical help or contact a Poison Control Center right away.
Stop Use and Consult A Doctor. (stop use and consult a doctor.)


Advanced Ingredient Data


Raw Label Data

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