SHISEIDO ULTIMATE SUN PROTECTION- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray

SHISEIDO ULTIMATE SUN PROTECTION by

Drug Labeling and Warnings

SHISEIDO ULTIMATE SUN PROTECTION by is a Otc medication manufactured, distributed, or labeled by SHISEIDO AMERICAS CORPORATION, SHISEIDO AMERICA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
AVOBENZONE 3.0%	Sunscreen
HOMOSALATE 15.0%	Sunscreen
OCTISALATE 5.0%	Sunscreen
OCTOCRYLENE 2.5%	Sunscreen
OXYBENZONE 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

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.

When using this product keep away from face to avoid breathing it.

Flammable

Do not use near heat, flame, or while smoking

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
• 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

Inactive Ingredients

SD ALCOHOL 40-B, DIMETHICONE, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, BUTYLENE GLYCOL, XYLITOL, SYZYGIUM JAMBOS LEAF EXTRACT, PEG/PPG-14/7 DIMETHYL ETHER, ACRYLATES/OCTYLACRYLAMIDE COPOLYMER, WATER, FRAGRANCE,

Other information

• protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 150 mL Bottle Carton

SHI SEIDO

Anti-Aging Suncare

50+

Ultimate
Sun Protection Spray

BROAD SPECTRUM
SPF 50+

For Face/Body

WATER RESISTANT
(80 MINUTES)

SUNSCREEN

150mL 5 FL. OZ.

INGREDIENTS AND APPEARANCE

SHISEIDO ULTIMATE SUN PROTECTION 
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58411-142
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.98 mg  in 132.6 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	19.89 mg  in 132.6 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	6.63 mg  in 132.6 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3.32 mg  in 132.6 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6.63 mg  in 132.6 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
XYLITOL (UNII: VCQ006KQ1E)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58411-142-80	1 in 1 CARTON	04/01/2014
1		132.6 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2014

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Establishment
Name	Address	ID/FEI	Business Operations
SHISEIDO AMERICA INC.		782677132	manufacture(58411-142) , analysis(58411-142)