FDA.reportPublic FDA data

UNID Sea Fennel Tinted Sun Protector

Manufacturer
Sage Pharmaceuticals Inc
Effective date
2025-12-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-06-03 17:46:36

Label at a glance#

ProductUNID Sea Fennel Tinted Sun Protector
Active ingredientTITANIUM DIOXIDE
Label structure10 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

Shake well before using. Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. 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 of 15 or higher and other sun protection measures including: Limit time ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 8.28%

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.

Warnings

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 useand ask a doctor if rash occurs.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well before using.
  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • 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 of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10 a.m.–2 p.m.
    • Wear long-sleeve shirts, pants, hats, and sunglasses.
  • Children under 6 months of age: ask a doctor.

OTHER SAFETY INFORMATION

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Coco-caprylate/Caprate, Caprylic/Capric Triglyceride, Polyglyceryl-3 Diisostearate, Caprylyl Methicone, Pentylene Glycol, Ethylhexyl Triazone, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Glycerin, Sodium Chloride, Glycosyl Trehalose, Iron Oxide (CI 77492), Hydrogenated Starch Hydrolysate, Tocopheryl Acetate, Crithmum Maritimum Callus Culture Filtrate, Isopropyl Titanium Triisostearate, Dimethicone, Iron Oxide (CI 77491), Alumina, Iron Oxide (CI 77499), Hedychium Coronarium Root Extract

SPL UNCLASSIFIED SECTION

Sage Pharmaceuticals Inc

Product of Taiwan

Manufactured for IDAQS Biotech, Inc.

Distributed by Beauty River International Inc.
901 S. Fremont Ave 108, Alhambra, CA 91803-4703, USA

Package Label (30mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer boxOuter box

Package Label (5mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer boxOuter box

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850054540751GTIN-13: 0850054540751
EAN-13: 0850054540751
GTIN-12: 850054540751
UPC-A: 850054540751
GTIN storage (14 digits): 00850054540751		SeaFennelTinted_30mL.jpg
BarcodeEAN-130850054540782GTIN-13: 0850054540782
EAN-13: 0850054540782
GTIN-12: 850054540782
UPC-A: 850054540782
GTIN storage (14 digits): 00850054540782		SeaFennelTinted_5mL.jpg

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
83119-24583119-245-50, 83119-245-51

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
ALUMINALMI26O6933IACT
CAPRYLYL METHICONEQ95M2P1KJLIACT
CRITHMUM MARITIMUMJ7IHY79BKYIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
CI 774911K09F3G675IACT
HEDYCHIUM CORONARIUM ROOT92A6N0IQN9IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
ISOPROPYL TITANIUM TRIISOSTEARATE949E3KBJ1IIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
PENTYLENE GLYCOL50C1307PZGIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
WATER059QF0KO0RIACT
CI 77499XM0M87F357IACT
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATEANQ870JD20IACT
GLUCOSYL TREHALOSE76B4LOB2YCIACT
DIMETHICONE92RU3N3Y1OIACT
ETHYLHEXYL TRIAZONEXQN8R9SAK4IACT
CI 77492EX438O2MRTIACT
HYDROGENATED STARCH HYDROLYSATE27F77DSJ5VIACT
SODIUM CHLORIDE451W47IQ8XIACT

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
46aa6160-903f-fab5-e063-6294a90a0e2c45a83a25-03fc-0d5d-e063-6394a90a49be2025-12-23WarningsExact identifier
spl id: 46aa6160-903f-fab5-e063-6294a90a0e2c
spl set id: 45a83a25-03fc-0d5d-e063-6394a90a49be

Reported adverse events (FAERS/openFDA)#

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