SHISEIDO ULTIMATE SUN PROTECTION PLUS- octinoxate, octocrylene, titanium dioxide, and zinc oxide lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM), TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

Available from:

SHISEIDO AMERICA INC.

INN (International Name):

OCTINOXATE

Composition:

OCTINOXATE 8673 mg in 100 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- 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

Authorization status:

OTC monograph not final

Summary of Product characteristics

SHISEIDO ULTIMATE SUN PROTECTION PLUS- OCTINOXATE, OCTOCRYLENE,
TITANIUM DIOXIDE,
AND ZINC OXIDE LOTION
SHISEIDO AMERICA INC.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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SHISEIDO SUNCARE ULTIMATE SUN PROTECTION
LOTION +
_DRUG FACTS_
_ACTIVE INGREDIENTS:_
_PURPOSE_
OCTINOXATE 7.4%
Sunscreen
OCTOCRYLENE 3.0%
Sunscreen
TITANIUM DIOXIDE 1.7%
Sunscreen
ZINC OXIDE 19.3%
Sunscreen
US ES
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.
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
INACTIVE INGREDIENTS
WATER, DIMETHICONE, BUTYLENE GLYCOL, ISOPROPYL MYRISTATE, SD ALCOHOL
40-
B, ISODODECANE, POLYMETHYL METHACRYLATE, PEG-9 POLYDIMETHYLSILOXYETHYL
DIMETHICONE, TRIMETHYLSILOXYSILICATE, POLYBUTYLENE GLYCOL/PPG-9/1
COPOLYMER, XYLITOL, GLYCERIN, METHYL GLUCETH-10, SAXIFRAGA SARMENTOSA
EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, ECTOIN, SOPHORA
ANGUSTIFOLIA ROOT EXTRACT, HYDROGENATED POLYDECENE, HYDROGEN
DIMETHICONE, ISOSTEARIC