Shiseido Ultimate Sun Protector Spray
FDA Label NDC 58411-891

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shiseido Americas Corporation for the product Shiseido Ultimate Sun Protector (NDC 58411-891). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Otc - Purpose

→ Uses

→ Warnings

→ Otc - Do Not Use

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Flammable

→ Directions

→ Inactive Ingredients

→ Other Information

→ Questions Or Comments?

→ Principal Display Panel - 150 Ml Cartridge Carton

Other

Drug Facts

Otc - Purpose

Active ingredients	Purpose
AVOBENZONE 2.3%	Sunscreen
HOMOSALATE 10.0%	Sunscreen
OCTISALATE 5.0%	Sunscreen
OCTOCRYLENE 5.0%	Sunscreen

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

Warnings

For external use only

Otc - Do Not Use

Do not useon damaged or broken skin

Otc - When Using

When using this productkeep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctorif rash occurs.

Otc - Keep Out Of Reach Of Children

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

Directions

For sunscreen use:

spray liberally and spread evenly by hand 15 minutes before sun exposure
hold container 4 to 6 inches from the skin to apply.
do not spray directly into face. Spray on hands then apply to face.
do not apply in windy conditions.
use in a well-ventilated area.
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

Inactive Ingredients

ALCOHOL DENAT.•DIISOPROPYL SEBACATE•TRIETHYLHEXANOIN•C12-15 ALKYL BENZOATE•DIMETHICONE•CAPRYLYL METHICONE•SILICA DIMETHYL SILYLATE•DIPROPYLENE GLYCOL•PPG-3 DIPIVALATE•VITIS VINIFERA (GRAPE) SEED OIL•PEG/PPG-14/7 DIMETHYL ETHER•LECITHIN•GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT•PPG-17•HYDROXYSTEARIC ACID•POLYHYDROXYSTEARIC ACID•POLYAMIDE-8•PALMITIC ACID•LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE•BHT•TOCOPHEROL•PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE•PHENOXYETHANOL•FRAGRANCE•