Drugplain

SHISEIDO ULTIMATE SUN PROTECTOR 3.1533 g/150mL

AVOBENZONE, HOMOSALATE, OCTISALATE, and OCTOCRYLENE · SPRAY · SHISEIDO AMERICAS CORPORATION

No Recall History
Plain English

SHISEIDO ULTIMATE SUN PROTECTOR is a spray containing avobenzone, homosalate, octisalate, and octocrylene at 3.1533 g/150mL, taken topical. Manufactured by SHISEIDO AMERICAS CORPORATION.

Key Facts

Brand Name
SHISEIDO ULTIMATE SUN PROTECTOR
Generic Name
AVOBENZONE, HOMOSALATE, OCTISALATE, and OCTOCRYLENE
NDC Code (Product)
58411-891
Manufacturer
SHISEIDO AMERICAS CORPORATION
Strength
3.1533 g/150mL
Dosage Form
SPRAY
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
03/01/2024

Recall History

No Recall History

Side Effects Reported to FDA

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

acute myeloid leukaemia2 reports
exposure to toxic agent2 reports
product contamination chemical2 reports
anaphylactic reaction1 reports
application site erythema1 reports
application site exfoliation1 reports
application site pain1 reports
application site pruritus1 reports
application site swelling1 reports
dizziness1 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 For sunscreen use: apply liberally 15 minutes before sun exposure 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 this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. – 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses children under 6 months: 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 product is swallowed, get medical help or contact a Poison Control Center right away. Flammable Do not use near heat, flame, or while smoking

Frequently Asked Questions

What is SHISEIDO ULTIMATE SUN PROTECTOR used for?

SHISEIDO ULTIMATE SUN PROTECTOR contains AVOBENZONE, HOMOSALATE, OCTISALATE, and OCTOCRYLENE. It is a spray taken topical. Consult your doctor for specific uses.

Is SHISEIDO ULTIMATE SUN PROTECTOR a controlled substance?

SHISEIDO ULTIMATE SUN PROTECTOR is not classified as a controlled substance by the DEA.

What is the generic name for SHISEIDO ULTIMATE SUN PROTECTOR?

The generic name for SHISEIDO ULTIMATE SUN PROTECTOR is AVOBENZONE, HOMOSALATE, OCTISALATE, and OCTOCRYLENE. There are 12 other brand versions of AVOBENZONE, HOMOSALATE, OCTISALATE, and OCTOCRYLENE.

What is the NDC code for SHISEIDO ULTIMATE SUN PROTECTOR 3.1533 g/150mL?

The NDC (National Drug Code) for SHISEIDO ULTIMATE SUN PROTECTOR 3.1533 g/150mL is 58411-891, listed by SHISEIDO AMERICAS CORPORATION.