Big Mood Spf 30 Milky Lip Balm

Big Mood Spf 30 Milky Lip Balm
SPL v3
SPL
SPL Set ID c83098af-3cf9-78f6-e053-2995a90a0d01
Route
TOPICAL
Published
Effective Date 2021-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (80 mg)
Inactive Ingredients
Tricaprylin Argan Oil Yellow Wax Almond Oil Jojoba Oil Shea Butter Candelilla Wax Methyl Salicylate Medium-chain Triglycerides .alpha.-tocopherol Acetate Carnauba Wax Oat Levomenol Sunflower Oil Tocopherol Soybean Oil Glyceryl Caprylate Polyglyceryl-3 Pentaricinoleate Isostearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-12-01

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 ) decreases the risk of skin cancer and early skin aging caused by the sun Directions
Warnings

For external use only

Directions
  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  •  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 value of 15 or higher and other sun protection measures including: Sun Protection Measures:
  • Limit time in the sun, especially from 10 a.m to 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses
  • Children under 6 months of age: Ask a doctor
Do Not Use

on damaged or broken skin

Drug Facts

Other Information

Protect the product in this container from excessive heat and direct sun. Store below 86°F/30°C

Package Labeling:

Active Ingredients

Zinc Oxide 8%

Inactive Ingredients

Prunus Amygdalus Dulcis (Sweet Almond) Oil, Cera Alba (Beeswax), Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Euphorbia Cerifera (Candelilla) Wax, Flavor, Argania Spinosa Kernal (Argan) Oil, Caprylic/capric Triglyceride, Tocopheryl Acetate, Copernicia Cerifera (Carnauba) Wax, Avena Sativa Kernel (Oat) Oil, Agave Tequilana Stem Extract, Bisabolol, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Stevia Rebaudiana Extract, Glycine Soja (Soybean) Oil, Glyceryl Caprylate, Polyhydroxystearic Acid, Polyglyceryl-3-Polyricinoleate, Isostearic Acid, Lecithin, Glyceryl Undecylenta

When Using This Product

keep out of eyes, rinse with water to remove

Stop Use and Ask A Doctor

if rash occurs

Keep Out of Reach of Children.

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


Structured Label Content

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

Sunscreen

Warnings

For external use only

Directions
  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  •  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 value of 15 or higher and other sun protection measures including: Sun Protection Measures:
  • Limit time in the sun, especially from 10 a.m to 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses
  • Children under 6 months of age: Ask a doctor
Do Not Use (Do not use)

on damaged or broken skin

Drug Facts

Other Information

Protect the product in this container from excessive heat and direct sun. Store below 86°F/30°C

Package Labeling:

Active Ingredients

Zinc Oxide 8%

Inactive Ingredients

Prunus Amygdalus Dulcis (Sweet Almond) Oil, Cera Alba (Beeswax), Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Euphorbia Cerifera (Candelilla) Wax, Flavor, Argania Spinosa Kernal (Argan) Oil, Caprylic/capric Triglyceride, Tocopheryl Acetate, Copernicia Cerifera (Carnauba) Wax, Avena Sativa Kernel (Oat) Oil, Agave Tequilana Stem Extract, Bisabolol, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Stevia Rebaudiana Extract, Glycine Soja (Soybean) Oil, Glyceryl Caprylate, Polyhydroxystearic Acid, Polyglyceryl-3-Polyricinoleate, Isostearic Acid, Lecithin, Glyceryl Undecylenta

When Using This Product (When using this product)

keep out of eyes, rinse with water to remove

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs

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


Advanced Ingredient Data


Raw Label Data

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