UNID SUN CUSHION BABY AND KID- titanium dioxide, zinc oxide lotion

UNID Sun Cushion baby and kid by

Drug Labeling and Warnings

UNID Sun Cushion baby and kid by is a Otc medication manufactured, distributed, or labeled by Sage Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Titanium Dioxide 9.72%

Zinc Oxide 9.50%

Purpose

Sunscreen

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

Warnings

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

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.

SPL UNCLASSIFIED SECTION

Manufactured for IDAQS Biotech, Inc.
901 S. Fremont Ave Ste 108, Alhambra, CA 91803, USA

MADE IN TAIWAN

Package Labeling

Package Labeling (Jar bottom label)

Package Labeling (REFILL)

INGREDIENTS AND APPEARANCE

UNID SUN CUSHION BABY AND KID 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83119-241
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9.72 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
LAMINARIA OCHROLEUCA (UNII: 4R2124HE76)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
STEARIC ACID (UNII: 4ELV7Z65AP)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
OCTYLDODECANOL (UNII: 461N1O614Y)
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83119-241-50	1 in 1 BOX	12/10/2025
1		13 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 83119-241-51	1 in 1 POUCH	12/10/2025
2		13 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/10/2025

Labeler - Sage Pharmaceuticals Inc (656245476)

Registrant - Sage Pharmaceuticals Inc (656245476)

Establishment
Name	Address	ID/FEI	Business Operations
Sage Pharmaceuticals Inc		656245476	manufacture(83119-241)