Zinc Oxide - Utu Co | Filltech USA, LLC

Manufacturer
Utu Co | Filltech USA, LLC
Effective date
2026-08-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-09-01 13:01:58

Label at a glance#

ProductUtu Broad Spectrum SPF 30 Moisturizing Body Sunscreen
Active ingredientZINC OXIDE
Label structure7 sections

Indications and 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.

Dosage and administration

Apply liberally and evenly 15 minutes before sun exposure. Reapply: • After 40 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 value of 15 or higher and other sun protection measures including:...

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally and evenly 15 minutes before sun exposure.
Reapply:
• After 40 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 value of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10am-2pm.
• Wear long-sleeved shirts, pants, hats, sunglasses.

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Coco-Caprylate/Caprate, Caprylic/Capric Triglyceride, Glyceryl Citrate/Lactate/Linoleate/Oleate, Glyceryl Stearate SE, Simmondsia Chinensis (Jojoba) Seed Oil, Glycerine, Sesamum Indicum (Sesame) Seed Oil, Hydrogenated Ethylhexyl Olivate, Isostearic Acid, Polyglyceryl-3 Polyricinoleate, Vegetable Oil, Benzyl Alcohol, Glyceryl Caprylate, Ascorbic Acid, Hydrogenated Olive Oil Unsaponifiables, Xanthan Gum, Glyceryl Undecylenate, Tocopherol, Aloe Barbadensis Leaf Juice, Citric Acid, Hippophae Rhamnoides Fruit Oil, Sodium Phytate, Helianthus Annuus (Sunflower) Seed Oil, Curcuma Longa (Turmeric) Root Extract, Sodium Hyaluronate, Limnanthes Alba (Meadowfoam) Seed Oil, Glyceryl Behenate, Haematococcus Pluvialis Extract.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Utu Broad Spectrum SPF 30 Moisturizing Body Sunscreen carton labelUtu Broad Spectrum SPF 30 Moisturizing Body Sunscreen carton labelUtu
Outdoor Skincare®
Broad Spectrum SPF 30 Moisturizing Body Sunscreen
Mineral Zinc Oxide 20%
Water Resistant 40min
Hyaluronic acid, sea-buckthorn, jojoba & sesame seed oil, vitamin C&E, astaxanthin, aloe.
5.5oz/156g

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130198715074352GTIN-13: 0198715074352
EAN-13: 0198715074352
GTIN-12: 198715074352
UPC-A: 198715074352
GTIN storage (14 digits): 00198715074352
Utu_Body_Packaging_CDER.jpg

Products#

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

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87952-00487952-004-01, 87952-004-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 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
Utu Broad Spectrum SPF 30 Moisturizing Body SunscreenZINC OXIDEUtu Co59938ace-c97c-d758-e063-6394a90a77e42026-08-28WarningsExact identifier
ndc (package): 87952-004-02
ndc (package): 87952-004-01
ndc (product): 87952-004
ndc11 (package): 87952000402
ndc11 (package): 87952000401
spl id: 5a1fb72d-0658-6b6c-e063-6394a90abaa8
spl set id: 59938ace-c97c-d758-e063-6394a90a77e4

Reported adverse events (FAERS/openFDA)#

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