SABAL Mineral Sunscreen Broad Sprectrum SPF 30 140 mg/mL

ZINC OXIDE · LOTION · SABAL SUN LLC

No Recall History

Plain English

SABAL Mineral Sunscreen Broad Sprectrum SPF 30 is a lotion containing zinc oxide at 140 mg/mL, taken topical. Manufactured by SABAL SUN LLC.

Key Facts

Brand Name: SABAL Mineral Sunscreen Broad Sprectrum SPF 30
Generic Name: ZINC OXIDE
NDC Code (Product): 84446-505
Manufacturer: SABAL SUN LLC
Strength: 140 mg/mL
Dosage Form: LOTION
Route: TOPICAL
Marketing Status
Application #: M020
Marketing Start: 06/11/2024

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

Dosage & Administration

Directions: Apply liberally 15 minutes before sun exposure and as needed. Children under 6 months of age: ask a doctor. Reapply at least every two hours, after 80 minutes of swimming or sweating, or immediately after towel drying. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am - 2pm. Wear long sleeve shirts, pants, hats, and sunglasses.

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 doctor if rash or irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breastfeeding, ask a health professional before use.

Frequently Asked Questions

What is SABAL Mineral Sunscreen Broad Sprectrum SPF 30 used for?

SABAL Mineral Sunscreen Broad Sprectrum SPF 30 contains ZINC OXIDE. It is a lotion taken topical. Consult your doctor for specific uses.

Is SABAL Mineral Sunscreen Broad Sprectrum SPF 30 a controlled substance?

SABAL Mineral Sunscreen Broad Sprectrum SPF 30 is not classified as a controlled substance by the DEA.

What is the generic name for SABAL Mineral Sunscreen Broad Sprectrum SPF 30?

The generic name for SABAL Mineral Sunscreen Broad Sprectrum SPF 30 is ZINC OXIDE. There are 12 other brand versions of ZINC OXIDE.

What is the NDC code for SABAL Mineral Sunscreen Broad Sprectrum SPF 30 140 mg/mL?

The NDC (National Drug Code) for SABAL Mineral Sunscreen Broad Sprectrum SPF 30 140 mg/mL is 84446-505, listed by SABAL SUN LLC.

Product NDC

84446-505

Package NDC

84446-505-00

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)