85448-003 Ultra Sunscreen

Manufacturer
Jiangsu Senwo Medical Technology Co., Ltd.
Effective date
2026-04-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:52:48

Label at a glance#

ProductUltra Sunscreen
Active ingredientOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

Soothing + Moisturizing

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 SECTION


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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85448-003-01Ultra Sunscreen473 mL in 1 BOTTLEEMULSION4731

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85448-00385448-003-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ultra SunscreenOCTINOXATE, OCTISALATE, TITANIUM DIOXIDEJiangsu Senwo Medical Technology Co., Ltd.4ed974b8-6c11-08e0-e063-6294a90a77132026-04-07WarningsExact identifier
ndc (package): 85448-003-01
ndc (product): 85448-003
ndc11 (package): 85448000301
spl id: 4ed974b8-6c12-08e0-e063-6294a90a7713
spl set id: 4ed974b8-6c11-08e0-e063-6294a90a7713

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.