unid sun cushion baby and kid spf50

unid sun cushion baby and kid spf50
SPL v2
SPL
SPL Set ID 4591e2fb-0b73-8ddb-e063-6294a90a5596
Route
topical
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (9.72 g) zinc oxide (9.5 g)
Inactive Ingredients
laminaria ochroleuca polyglyceryl-3 diisostearate stearic acid pentylene glycol coco-caprylate/caprate propanediol sodium hyaluronate butylene glycol water caprylic/capric triglyceride octyldodecanol saccharomyces cerevisiae aluminum hydroxide sodium chloride triethoxycaprylylsilane .alpha.-tocopherol acetate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-12-10
Purpose

Sunscreen

Description

Titanium Dioxide 9.72% Zinc Oxide 9.50%

Medication Information

Warnings

For external use only

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
Purpose

Sunscreen

Directions
  • 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 Information

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

Inactive Ingredients

Water, Coco-Caprylate/Caprate, Caprylic/Capric Triglyceride, Octyldodecanol, Polyglyceryl-3 Diisostearate, Saccharomyces/Rice Ferment Filtrate, Pentylene Glycol, Aluminum Hydroxide, Stearic Acid, Sodium Chloride, Tocopheryl Acetate, Triethoxycaprylylsilane, Propanediol, Laminaria Ochroleuca Extract, Sodium Hyaluronate, Butylene Glycol, Hydrolyzed Sodium Hyaluronate.

Description

Titanium Dioxide 9.72% Zinc Oxide 9.50%

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

Package Labeling

Active Ingredients

Titanium Dioxide 9.72%

Zinc Oxide 9.50%

Package Labeling (refill)

Package Labeling (jar Bottom Label)

Structured Label Content

Warnings

For external use only

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
Purpose

Sunscreen

Directions
  • 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 Information (Other information)

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

Inactive Ingredients

Water, Coco-Caprylate/Caprate, Caprylic/Capric Triglyceride, Octyldodecanol, Polyglyceryl-3 Diisostearate, Saccharomyces/Rice Ferment Filtrate, Pentylene Glycol, Aluminum Hydroxide, Stearic Acid, Sodium Chloride, Tocopheryl Acetate, Triethoxycaprylylsilane, Propanediol, Laminaria Ochroleuca Extract, Sodium Hyaluronate, Butylene Glycol, Hydrolyzed Sodium Hyaluronate.

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

Package Labeling

Active Ingredients

Titanium Dioxide 9.72%

Zinc Oxide 9.50%

Package Labeling (refill) (Package Labeling (REFILL))

Package Labeling (jar Bottom Label) (Package Labeling (Jar bottom label))

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:53.443544 · Updated: 2026-03-14T23:11:51.346073