Big Mood SPF 30 Milky Lip Balm 80 mg/g

ZINC OXIDE · STICK · Everyday Group Limited

No Recall History

Plain English

Big Mood SPF 30 Milky Lip Balm is a stick containing zinc oxide at 80 mg/g, taken topical. Manufactured by Everyday Group Limited.

Key Facts

Brand Name: Big Mood SPF 30 Milky Lip Balm
Generic Name: ZINC OXIDE
NDC Code (Product): 72098-004
Manufacturer: Everyday Group Limited
Strength: 80 mg/g
Dosage Form: STICK
Route: TOPICAL
Marketing Status
Application #: M020
Marketing Start: 12/01/2021

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective506 reports

macular degeneration453 reports

off label use313 reports

pyrexia303 reports

nausea284 reports

pain280 reports

malaise259 reports

weight decreased235 reports

therapeutic product effect incomplete213 reports

headache201 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

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

Warnings

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

Frequently Asked Questions

What is Big Mood SPF 30 Milky Lip Balm used for?

Big Mood SPF 30 Milky Lip Balm contains ZINC OXIDE. It is a stick taken topical. Consult your doctor for specific uses.

Is Big Mood SPF 30 Milky Lip Balm a controlled substance?

Big Mood SPF 30 Milky Lip Balm is not classified as a controlled substance by the DEA.

What is the generic name for Big Mood SPF 30 Milky Lip Balm?

The generic name for Big Mood SPF 30 Milky Lip Balm is ZINC OXIDE. There are 11 other brand versions of ZINC OXIDE.

What is the NDC code for Big Mood SPF 30 Milky Lip Balm 80 mg/g?

The NDC (National Drug Code) for Big Mood SPF 30 Milky Lip Balm 80 mg/g is 72098-004, listed by Everyday Group Limited.

Product NDC

72098-004

Package NDC

72098-004-01

Other Zinc Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)