Unid Sea Fennel Tinted Sun Protector

Unid Sea Fennel Tinted Sun Protector
SPL v3
SPL
SPL Set ID 45a83a25-03fc-0d5d-e063-6394a90a49be
Route
TOPICAL
Published
Effective Date 2025-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (8.28 g)
Inactive Ingredients
Alumina Caprylyl Methicone Crithmum Maritimum Caprylic/capric Triglyceride Glycerin Ci 77491 Hedychium Coronarium Root .alpha.-tocopherol Acetate, Dl- Coco-caprylate/caprate Isopropyl Titanium Triisostearate Polyglyceryl-3 Diisostearate Pentylene Glycol Water Ci 77499 Diethylamino Hydroxybenzoyl Hexyl Benzoate Glucosyl Trehalose Dimethicone Ethylhexyl Triazone Ci 77492 Hydrogenated Starch Hydrolysate Sodium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-18
Description

Titanium Dioxide 8.28%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 8.28%

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.
Section 42229-5

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

Section 50565-1
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9
  • Stop use and ask a doctor if rash occurs.
Section 50567-7
  • When using this product, keep out of eyes. Rinse with water to remove.
Section 50570-1
  • Do not use on damaged or broken skin.
Section 60561-8
  • Protect the product in this container from excessive heat and direct sun.
Warnings
  • For external use only.
Directions
  • 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.
Active Ingredients

Titanium Dioxide 8.28%

Package Label (5ml)

Inactive Ingredients

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

Package Label (30ml)

Structured Label Content

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.
Section 42229-5 (42229-5)

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

Section 50565-1 (50565-1)
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
  • Stop use and ask a doctor if rash occurs.
Section 50567-7 (50567-7)
  • When using this product, keep out of eyes. Rinse with water to remove.
Section 50570-1 (50570-1)
  • Do not use on damaged or broken skin.
Section 60561-8 (60561-8)
  • Protect the product in this container from excessive heat and direct sun.
Purpose

Sunscreen

Warnings
  • For external use only.
Directions
  • 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.
Active Ingredients

Titanium Dioxide 8.28%

Package Label (5ml) (Package Label (5mL))

Inactive Ingredients

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

Package Label (30ml) (Package Label (30mL))

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:53.444721 · Updated: 2026-03-14T23:11:51.346073