FDA.reportPublic FDA data

UNID Sun Cushion baby and kid

Manufacturer
Sage Pharmaceuticals Inc
Effective date
2025-12-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:46:36

Label at a glance#

ProductUNID Sun Cushion baby and kid
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure11 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

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 ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 9.72%

Zinc Oxide 9.50%

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 use and 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

  • 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 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, 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

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 Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sun cushionSun cushion

Package Labeling (Jar bottom label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Jar bottom labelJar bottom label

Package Labeling (REFILL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RefillRefill

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850054540744GTIN-13: 0850054540744
EAN-13: 0850054540744
GTIN-12: 850054540744
UPC-A: 850054540744
GTIN storage (14 digits): 00850054540744		Sun_Cushion_Refill.jpg
BarcodeEAN-130850054540843GTIN-13: 0850054540843
EAN-13: 0850054540843
GTIN-12: 850054540843
UPC-A: 850054540843
GTIN storage (14 digits): 00850054540843		Sun cushion.jpg

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83119-24183119-241-50, 83119-241-51

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
LAMINARIA OCHROLEUCA4R2124HE76IACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
STEARIC ACID4ELV7Z65APIACT
PENTYLENE GLYCOL50C1307PZGIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
PROPANEDIOL5965N8W85TIACT
SODIUM HYALURONATEYSE9PPT4THIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
WATER059QF0KO0RIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
OCTYLDODECANOL461N1O614YIACT
SACCHAROMYCES CEREVISIAE978D8U419HIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
SODIUM CHLORIDE451W47IQ8XIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
46aa65bf-3bc3-f639-e063-6394a90afa504591e2fb-0b73-8ddb-e063-6294a90a55962025-12-23WarningsExact identifier
spl id: 46aa65bf-3bc3-f639-e063-6394a90afa50
spl set id: 4591e2fb-0b73-8ddb-e063-6294a90a5596

Reported adverse events (FAERS/openFDA)#

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