ULTRA SUNSCREEN- octinoxate, octisalate, titanium dioxide emulsion

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Methoxy cinnamic acid ethylhexyl ester 7.5%
Diethanolamine hydroxybenzyl benzoate 3.5%
Octyl methoxycinnamate 1.5%
Titanium dioxide 2.7%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Soothing + Moisturizing

WARNINGS

For external use only.

DO NOT USE

Do not use on damaged or broken skin.

WHEN USING

When using this product, keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs.

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. May stain some fabrics.

DOSAGE & ADMINISTRATION

Shake well.
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 asunscreen with a Broad Spectrum SPF value of 15 or higher and other sunprotection measures including: limit time in the sun, especially from 10 a.m.- 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months: Ask a doctor.

INACTIVE INGREDIENT

Water, Glycerin, Methylpropanediol, Dibutyl Adipate, Alcohol, Ammonium PolyacryloyldimethylTaurate, Octyldodecyl Neopentanoate, 1,2-Hexanediol, Hydroxyacetophenone, Olive OilPolyglyceryl-6 Esters, Sorbitan Sesquioleate, Trideceth-10, Polyglyceryl-2Dipolyhydroxystearate, Polyglyceryl-6 Oleate, Sodium Polyacryloyldimethyl Taurate, C13-16Isoparaffin, Bisabolol, Polyglyceryl-10 Myristate, Fragrance, Allantoin, Polyglyceryl-3 Distearate,Aluminum Hydroxide, Stearic Acid, Hydrolyzed Sodium Hyaluronate, Butylene Glycol, 1.2-Pentanediol, Bacillus/Soybean Ferment Extract, Folic Acid, Sodium Hyaluronate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTRA SUNSCREEN 
octinoxate, octisalate, titanium dioxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85448-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.09 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.035 g  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.027 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIBUTYL ADIPATE (UNII: F4K100DXP3)
FOLIC ACID (UNII: 935E97BOY8)
HYDROLYZED SODIUM HYALURONATE 10 (UNII: AAZ2QV38TA)
BISABOLOL (UNII: 24WE03BX2T)
BACILLUS PUMILUS (UNII: FLS0C20S53)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALCOHOL (UNII: 3K9958V90M)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
OLIVE OIL POLYGLYCERYL-6 ESTERS (UNII: 4KDO9AFM9I)
SODIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: NG5NG5733T)
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: F01RIY4371)
C13-16 ISOPARAFFIN (UNII: LED42LZG6O)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
ALLANTOIN (UNII: 344S277G0Z)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIDECETH-10 (UNII: G624N6MSBA)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLYGLYCERYL-10 MYRISTATE (UNII: Y9WL8QN3ZB)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
POLYGLYCERYL-6 OLEATE (UNII: G4AYJ54K59)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85448-003-01	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/07/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/07/2026

Labeler - Jiangsu Senwo Medical Technology Co., Ltd. (569521612)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangsu Senwo Medical Technology Co., Ltd.		569521612	manufacture(85448-003)