Big Mood Spf 30 Milky Lip Balm Stick
FDA Label NDC 72098-004

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Everyday Group Limited for the product Big Mood Spf 30 Milky Lip Balm (NDC 72098-004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Zinc Oxide 8%

Purpose

Sunscreen

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

Do Not Use

on damaged or broken skin

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

Directions

  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply 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 value of 15 or higher and other sun protection measures including:
  • 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

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

Other Information

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

Package Labeling:

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