FDA.reportPublic FDA data

Utu Hydrating Sun Balm Broad Spectrum SPF 50 - 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 13:03:07

Label at a glance#

ProductUtu Hydrating Sun Balm Broad Spectrum SPF 50
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

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 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 value of 15 or higher and other sun protection measures includin...

Label contents#

Full prescribing information#

Uses

INDICATIONS & USAGE SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply liberally and evenly 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 value of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10am-2pm.
• Wear long-sleeve shirts, pants, hats and 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

If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Prunus Amygdalus Dulcis (Sweet Almond Oil), Vegetable Oil, Copernicia Cerifera (Carnauba) Wax, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Simmondsia Chinese (Jojoba) Seed Extract, Euphorbia Cerifera (Candelilla) Wax, Polyglyceryl-4 Olivate/Polyricinoleate, Elaeis Guineensis (Palm) Butter, Glyceryl Caprylate, Tapioca Starch, Polymethylsilsesquioxane, Tocopheryl Linoleate/Oleate, Cetearyl Alcohol, Water, Glyceryl Undecylenate, Hippophae Rhamnoides Fruit Oil, Tremella Fuciformis Sporocarp (Silver Ear Mushroom) Extract, Curcuma Longa (Turmeric) Root Extract, Ceramide NP, Bisabolol, Haematococcus Pluvialis Algae Extract.

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Purpose

OTC - PURPOSE SECTION

Sunscreen

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Utu Hydrating Sun Balm carton labelUtu Hydrating Sun Balm carton labelHydrating Sun Balm. SPF 50. Broad Spectrum.

Face & Lip Protector.

Mineral Zinc Oxide, ceramide NP, snow mushroom, sea buckthorn, jojoba oil, vitamin E, astaxanthin.

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87952-00387952-003-01, 87952-003-02, 87952-003-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
PALM OIL5QUO05548ZIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
COCOS NUCIFERA (COCONUT) OILQ9L0O73W7LIACT
.ALPHA.-TOCOPHEROL LINOLEATE, D-G0N132Q0EDIACT
HAEMATOCOCCUS PLUVIALIS31T0FF0472IACT
CERAMIDE NP4370DF050BIACT
GLYCERYL 1-UNDECYLENATEB68LJT9544IACT
HIPPOPHAE RHAMNOIDES FRUIT OILTA4JCF9S1JIACT
PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL66YXD4DKO9IACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
TAPIOCA STARCH24SC3U704IIACT
CETEARYL ALCOHOL2DMT128M1SIACT
BISABOLOL24WE03BX2TIACT
EUPHORBIA CERIFERA (CANDELILLA) WAXWL0328HX19IACT
CURCUMA LONGA (TURMERIC) ROOT856YO1Z64FIACT
WATER059QF0KO0RIACT
COPERNICIA CERIFERA (CARNAUBA) WAXR12CBM0EIZIACT
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)59Z907ZB69IACT
TREMELLA FUCIFORMIS FRUITING BODYGG8N28393GIACT
POLYGLYCERYL-4 OLIVATE/POLYRICINOLEATEWYX2KZL5BDIACT
ELAEIS GUINEENSIS (PALM) BUTTERUYH3R74N56IACT

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 Hydrating Sun Balm Broad Spectrum SPF 50ZINC OXIDEUtu Co59d1d0ac-2444-d6f9-e063-6294a90ae80c2026-08-28WarningsExact identifier
ndc (package): 87952-003-01
ndc (package): 87952-003-02
ndc (package): 87952-003-03
ndc (product): 87952-003
ndc11 (package): 87952000303
ndc11 (package): 87952000301
ndc11 (package): 87952000302
spl id: 5a202afd-9ad5-f139-e063-6394a90aaefb
spl set id: 59d1d0ac-2444-d6f9-e063-6294a90ae80c

Reported adverse events (FAERS/openFDA)#

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