FDA.reportPublic FDA data

LAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 Sunset Sands

Manufacturer
COSMAX USA, CORP
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
monthly-update
Hydrated at
2026-06-03 17:56:33

Label at a glance#

ProductLAURA GELLER X BLISS SHINE - N - SHIELD LIP BALM SPF 15 Sunset Sands
Active ingredientZINC OXIDE
Label structure7 sections

Indications and uses

Uses: Helps prevent sunburn

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply: After 80 minutes of swimming or sweating Immediately after towel drying After eating or drinking As often as necessary

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Zinc Oxide 13.5%

OTC - PURPOSE SECTION

Purpose

Sunscreen

USES

INDICATIONS & USAGE SECTION

Uses:

Helps prevent sunburn

WARNINGS SECTION

Warnings:

For external use only.

OTC - DO NOT USE SECTION

Do not useon damaged or broken skin.

OTC - WHEN USING SECTION

When using this product,keep out of eyes. rinse with water to remove

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.

OTC - STOP USE SECTION

Stop use and ask a doctorif rash occurs.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure. Reapply:
  • After 80 minutes of swimming or sweating
  • Immediately after towel drying
  • After eating or drinking
  • As often as necessary

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: DIISOSTEARYL MALATE, SILICA DIMETHYL SILYLATE, POLYBUTENE, CAPRYLIC/CAPRIC TRIGLYCERIDE, LECITHIN, ISOSTEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, POLYHYDROXYSTEARIC ACID, HYDROGENATED POLYISOBUTENE, BUTYLOCTYL SALICYLATE, MICROCRYSTALLINE WAX, BIS-DIGLYCERYL POLYACYLADIPATE-2, SORBITAN OLIVATE, ISONONYL ISONONANOATE, SORBITAN ISOSTEARATE, VP/HEXADECENE COPOLYMER, MENTHONE GLYCERIN ACETAL, DEHYDROACETIC ACID, FLAVOR, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491, CI 77492, CI 77499), YELLOW 5 LAKE (CI 19140), RED 7 LAKE (CI 15850).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TubeTubeCartonCartonLaura Geller Shine-n-Shield Lip Balm SPF 15 0.54 fl.oz./16ML

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
68577-22168577-221-01

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
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
DIISOSTEARYL MALATEQBS8A3XZGQIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
SORBITAN OLIVATEMDL271E3GRIACT
DEHYDROACETIC ACID2KAG279R6RIACT
FERROUS OXIDEG7036X8B5HIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYBUTENE (1400 MW)1NA5AO9GH7IACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
ISOSTEARIC ACIDX33R8U0062IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
FD&C YELLOW NO. 5 ALUMINUM LAKEJQ6BLH9FR7IACT
D&C RED NO. 7ECW0LZ41X8IACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
HYDROGENATED POLYISOBUTENE (1300 MW)7D1YQ9Y5EZIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
MENTHONE GLYCERIN ACETAL7QQ1EE6RCPIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
VP/HEXADECENE COPOLYMERKFR5QEN0N9IACT
ZINC OXIDESOI2LOH54ZACTIB

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
4bfcd44d-2f17-1dd3-e063-6294a90ae6bd49149609-185d-e9ee-e063-6294a90a7fb22026-03-01WarningsExact identifier
spl set id: 49149609-185d-e9ee-e063-6294a90a7fb2

Reported adverse events (FAERS/openFDA)#

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