Drugplain

Sunny Sailor Captain s Classic Clear Mineral Sunscreen SPF 40 225 mg/mL

ZINC OXIDE · CREAM · SUNNY SAILOR LLC

No Recall History
Plain English

Sunny Sailor Captain s Classic Clear Mineral Sunscreen SPF 40 is a cream containing zinc oxide at 225 mg/mL, taken topical. Manufactured by SUNNY SAILOR LLC.

Key Facts

Brand Name
Sunny Sailor Captain s Classic Clear Mineral Sunscreen SPF 40
Generic Name
ZINC OXIDE
NDC Code (Product)
85135-577
Manufacturer
SUNNY SAILOR LLC
Strength
225 mg/mL
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
12/17/2024

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 Higher SPF gives more sunburn protection Retains SPF after 80 minutes of swimming or sweating 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: 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 broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10a.m.- 2 p.m. Wear long-sleeved 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. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°. Stop use and ask a 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 breast-feeding, ask health professional before use.

Frequently Asked Questions

What is Sunny Sailor Captain s Classic Clear Mineral Sunscreen SPF 40 used for?

Sunny Sailor Captain s Classic Clear Mineral Sunscreen SPF 40 contains ZINC OXIDE. It is a cream taken topical. Consult your doctor for specific uses.

Is Sunny Sailor Captain s Classic Clear Mineral Sunscreen SPF 40 a controlled substance?

Sunny Sailor Captain s Classic Clear Mineral Sunscreen SPF 40 is not classified as a controlled substance by the DEA.

What is the generic name for Sunny Sailor Captain s Classic Clear Mineral Sunscreen SPF 40?

The generic name for Sunny Sailor Captain s Classic Clear Mineral Sunscreen SPF 40 is ZINC OXIDE. There are 12 other brand versions of ZINC OXIDE.

What is the NDC code for Sunny Sailor Captain s Classic Clear Mineral Sunscreen SPF 40 225 mg/mL?

The NDC (National Drug Code) for Sunny Sailor Captain s Classic Clear Mineral Sunscreen SPF 40 225 mg/mL is 85135-577, listed by SUNNY SAILOR LLC.