Drugplain

SunStation USA SPF-30 SPORT SUNSCREEN 63 g/896g

ZINC OXIDE · LOTION · RENU LABORATORIES, LLC

No Recall History
Plain English

SunStation USA SPF-30 SPORT SUNSCREEN is a lotion containing zinc oxide at 63 g/896g, taken topical. Manufactured by RENU LABORATORIES, LLC.

Key Facts

Brand Name
SunStation USA SPF-30 SPORT SUNSCREEN
Generic Name
ZINC OXIDE
NDC Code (Product)
76348-407
Manufacturer
RENU LABORATORIES, LLC
Strength
63 g/896g
Dosage Form
LOTION
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
02/20/2024

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 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. 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 this 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 between 10am and 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 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 a health professional before use.

Frequently Asked Questions

What is SunStation USA SPF-30 SPORT SUNSCREEN used for?

SunStation USA SPF-30 SPORT SUNSCREEN contains ZINC OXIDE. It is a lotion taken topical. Consult your doctor for specific uses.

Is SunStation USA SPF-30 SPORT SUNSCREEN a controlled substance?

SunStation USA SPF-30 SPORT SUNSCREEN is not classified as a controlled substance by the DEA.

What is the generic name for SunStation USA SPF-30 SPORT SUNSCREEN?

The generic name for SunStation USA SPF-30 SPORT SUNSCREEN is ZINC OXIDE. There are 12 other brand versions of ZINC OXIDE.

What is the NDC code for SunStation USA SPF-30 SPORT SUNSCREEN 63 g/896g?

The NDC (National Drug Code) for SunStation USA SPF-30 SPORT SUNSCREEN 63 g/896g is 76348-407, listed by RENU LABORATORIES, LLC.