Drug Facts

Active ingredients	Purpose
OCTINOXATE 4.9%	Sunscreen
TITANIUM DIOXIDE 7.4%	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.

Directions

For sunscreen use:

apply every before sun exposure and as needed
children under 6 months: Ask a doctor
reapply at least every two hour

Inactive Ingredients

CYCLOMETHICONE • WATER • DIPROPYLENE GLYCOL • SILICA • GLYCERIN • POLYMETHYLSILSESQUIOXANE • POLYMETHYL METHACRYLATE • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER • PEG-10 DIMETHICONE • DISTEARDIMONIUM HECTORITE • TRIMETHYLSILOXYSILICATE • PEG/PPG-36/41 DIMETHYL ETHER • LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL • ALUMINUM DISTEARATE • ALUMINUM HYDROXIDE • ISOSTEARIC ACID • TRISODIUM EDTA • DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE • POLYSILICONE-2 • BHT • TOCOPHEROL • METHICONE • TETRADECENE • PHENOXYETHANOL • IRON OXIDES • MICA • TITANIUM DIOXIDE

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

SHISEIDO

Refining
Makeup Primer

SPF 21
sunscreen

30mL
NET WT. 1.1 OZ.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

SHISEIDO REFINING MAKEUP PRIMER
octinoxate and titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-630
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.69 g in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.53 g in 30 mL

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE (UNII: NMQ347994Z)
WATER (UNII: 059QF0KO0R)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ISOSTEARIC ACID (UNII: X33R8U0062)
EDETATE TRISODIUM (UNII: 420IP921MB)
DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
METHICONE (20 CST) (UNII: 6777U11MKT)
1-TETRADECENE (UNII: FW23481S7S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-630-10	1 in 1 CARTON	01/01/2021
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	01/01/2021

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)