SHISEIDO ULTIMATE SUN PROTECTOR 1.8105 g/50mL

OCTISALATE, OCTOCRYLENE, ZINC OXIDE · CREAM · Shiseido Americas Corporation

No Recall History

Plain English

SHISEIDO ULTIMATE SUN PROTECTOR is a cream containing octisalate, octocrylene, zinc oxide at 1.8105 g/50mL, taken topical. Manufactured by Shiseido Americas Corporation.

Key Facts

Brand Name: SHISEIDO ULTIMATE SUN PROTECTOR
Generic Name: OCTISALATE, OCTOCRYLENE, ZINC OXIDE
NDC Code (Product): 58411-971
Manufacturer: Shiseido Americas Corporation
Strength: 1.8105 g/50mL
Dosage Form: CREAM
Route: TOPICAL
Marketing Status
Application #: M020
Marketing Start: 03/01/2025

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 OCTISALATE, OCTOCRYLENE, ZINC OXIDE. It is a cream 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 OCTISALATE, OCTOCRYLENE, ZINC OXIDE. There are 8 other brand versions of OCTISALATE, OCTOCRYLENE, ZINC OXIDE.

What is the NDC code for SHISEIDO ULTIMATE SUN PROTECTOR 1.8105 g/50mL?

The NDC (National Drug Code) for SHISEIDO ULTIMATE SUN PROTECTOR 1.8105 g/50mL is 58411-971, listed by Shiseido Americas Corporation.

Product NDC

58411-971

Package NDC

58411-971-60

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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)