FDA.reportPublic FDA data

XBALM Extreme Lip Protection SPF 15 Sunscreen & Lip Moisturizer

Manufacturer
Yusef Manufacturing Laboratories
Effective date
2026-11-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-11-10 04:06:51

Label at a glance#

ProductXBALM EXTREME ICE
Active ingredientOCTINOXATE, OXYBENZONE
Label structure15 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:  Octinoxate (7%), Oxybenzone (4%)

OTC - PURPOSE SECTION

Purpose: Sunscreen

INDICATIONS & USAGE SECTION

Uses:• Helps prevent sunburn • Higher SPF gives more sunburn protection.

WARNINGS SECTION

Warnings:  For external use only.When using this product: • Keep out of eyes • Rinse with water to remove • Stop use and ask a doctor if • rash or irritation develops and lasts.

DOSAGE & ADMINISTRATION SECTION

Directions:• Apply evenly 15 minutes before sun exposure and as needed • Reapply at least every 2 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Children under 6 months of age: ask a doctor.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:Petrolatum, Ozokerite, Beeswax, Mineral Oil, Coconut Oil, Flavor, Saccharin, Phenyl Trimethicone, Safflower Seed Oil, Aloe Oil, Vitamin E Acetate

Extreme Ice:Petrolatum, Ozokerite, Beeswax, Mineral Oil, Menthol, Camphor, Coconut Oil, Flavor, Saccharin, Phenyl Trimethicone, Safflower Seed Oil, Aloe Oil, Vitamin E Acetate

OTHER SAFETY INFORMATION

Other Information:Moderate sun protection product • Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

OTC - QUESTIONS SECTION

Questions?877.827.5425

SPL UNCLASSIFIED SECTION

Extreme Lip Protection • SPF 15 • UVA/UVB Protection

SPF 15 Sunscreen & Lip Moisturizer • net wt. 4.2 g

Tamper Sealed. Twist Cap to Break Seal.

MADE IN THE USA

DISTRIBUTED BY:XBALM, Clearfield, UT

PRINCIPAL DISPLAY PANEL - XBALM Extreme Tropical - NDC 10827-2001-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

XBALM Extreme Tropical • SPF 15 Sunscreen & Lip Moisturizer • net wt. 4.2 g

XBALM Extreme Tropical lip balm labelXBALM Extreme Tropical lip balm label

PRINCIPAL DISPLAY PANEL - XBALM Extreme Ice - NDC 10827-2002-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

XBALM Extreme Ice • SPF 15 Sunscreen & Lip Moisturizer • net wt. 4.2 g

XBALM Extreme Ice lip balm labelXBALM Extreme Ice lip balm label

PRINCIPAL DISPLAY PANEL - XBALM Extreme Vanilla Mint - NDC 10827-2003-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

XBALM Extreme Vanilla Mint • SPF 15 Sunscreen & Lip Moisturizer • net wt. 4.2 g

XBALM Extreme Vanilla Mint lip balm labelXBALM Extreme Vanilla Mint lip balm label

PRINCIPAL DISPLAY PANEL - XBALM Extreme Orange - NDC 10827-2004-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

XBALM Extreme Orange • SPF 15 Sunscreen & Lip Moisturizer • net wt. 4.2 g

XBALM Extreme Orange lip balm labelXBALM Extreme Orange lip balm label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850523001011GTIN-13: 0850523001011
EAN-13: 0850523001011
GTIN-12: 850523001011
UPC-A: 850523001011
GTIN storage (14 digits): 00850523001011		XBALM_2001_Extreme_Tropical.jpg, XBALM_2002_Extreme_Ice.jpg, XBALM_2004_Extreme_Orange.jpg, XBALM_2003_Extreme_Vanilla_Mint.jpg, XBALM_2005_Extreme_Sugar_Cookie.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
10827-200110827-2001-1
10827-200210827-2002-1
10827-200310827-2003-1
10827-200410827-2004-1
10827-200510827-2005-1

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 62 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
LIGHT MINERAL OILN6K5787QVPIACT
CERESINQ1LS2UJO3AIACT
WHITE WAX7G1J5DA97FIACT
MINERAL OILT5L8T28FGPIACT
MENTHOLL7T10EIP3AIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
COCONUT OILQ9L0O73W7LIACT
SACCHARIN CALCIUM5101OP7P2IIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
SAFFLOWER OIL65UEH262ISIACT
ALOEV5VD430YW9IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
LIGHT MINERAL OILN6K5787QVPIACT
CERESINQ1LS2UJO3AIACT
WHITE WAX7G1J5DA97FIACT
MINERAL OILT5L8T28FGPIACT
COCONUT OILQ9L0O73W7LIACT
SACCHARIN CALCIUM5101OP7P2IIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
SAFFLOWER OIL65UEH262ISIACT
ALOEV5VD430YW9IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
LIGHT MINERAL OILN6K5787QVPIACT
CERESINQ1LS2UJO3AIACT
WHITE WAX7G1J5DA97FIACT
MINERAL OILT5L8T28FGPIACT
COCONUT OILQ9L0O73W7LIACT
SACCHARIN CALCIUM5101OP7P2IIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
SAFFLOWER OIL65UEH262ISIACT
ALOEV5VD430YW9IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB

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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Note Mattifying Extreme Wear Foundation 130 Cool RoseOCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETIc52d92d9-e228-4840-aacc-ed97a61734432026-10-29WarningsName fallback
generic name: OCTINOXATE
Dr. C. Tuna Sun 6 SPF Tan and Care CarrotOCTINOXATEFarmasi US LLC67de9257-70f3-4444-a4a2-a8d7425fcc0e2026-01-09WarningsName fallback
generic name: OCTINOXATE
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E Golden 1OCTINOXATESHISEIDO AMERICAS CORPORATION8a9294c2-3933-4f9c-b7e6-1f446f441a162026-01-05WarningsName fallback
generic name: OCTINOXATE
GR LONGSTAY Matte Face Powder SPF 15OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI62759398-4935-4732-b950-cfbeab82bc5a2025-08-07WarningsName fallback
generic name: OCTINOXATE
GOLDEN ROSE CORRECT AND CONCEAL Concealer Cream PaletteOCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETIcca417c8-b882-48a7-8bd8-ccc6f961a3d22025-08-06WarningsName fallback
generic name: OCTINOXATE
GR TOTAL COVER 2 in 1 Foundation and Concealer SPF 15OCTINOXATEERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI038ec45a-0d56-4cd9-8060-767b382c12372025-08-06WarningsName fallback
generic name: OCTINOXATE
SHISEIDO REVITALESSENCE SKIN GLOW FOUNDATION 110OCTINOXATESHISEIDO AMERICAS CORPORATION393ce1fa-f188-45d0-a23e-2818de9749952025-03-13WarningsName fallback
generic name: OCTINOXATE
Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 26 SunscreenOCTINOXATEL'Oreal USA Products Inc7cc920de-c91f-4040-a0b9-ea216d6f9bd72024-12-23WarningsName fallback
generic name: OCTINOXATE
Lancome Paris Renergie Lift Makeup Broad Spectrum SPF 26 SunscreenOCTINOXATESICOS ET CIEc634eaab-f014-4155-a40b-9030e358ec122024-12-23WarningsName fallback
generic name: OCTINOXATE
Covergirl Outlast Extreme Wear 3-in-1 Foundation 24 HR Full Coverage SPF 18 Octinoxate Sunscreen Liquid FoundationOCTINOXATENoxell Corporation258e8f05-295e-8e32-e063-6294a90a75482024-11-21WarningsName fallback
generic name: OCTINOXATE
Rimmel London Lasting Finish 25 HR Foundation SPF 20OCTINOXATERimmelcfd041e9-ed40-dc93-e053-2995a90a96992024-11-19WarningsName fallback
generic name: OCTINOXATE
Lancome Paris Absolue Makeup Broad Spectrum SPF 20 Sunscreen Absolute Replenishing Makeup for Dry and Very Dry SkinOCTINOXATEL'Oreal USA Products Inc90326e7e-8fdf-4221-afc0-208774d8ba6f2024-06-28WarningsName fallback
generic name: OCTINOXATE
MAYBELLINE NEW YORK INSTANT AGE REWIND ERASER TREATMENT MAKEUP OCTINOXATE BROAD SPECTRUM SPF 20 SUNSCREEN PLUS PROVITAMIN B5OCTINOXATEL'Oreal USA Products Inc12ec5a93-8c24-4ac9-94df-910dd8137e002024-06-27WarningsName fallback
generic name: OCTINOXATE
Giorgio Armani Power Fabric Plus Weightless Matte Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATESICOS ET CIE3b49a970-653b-4256-b2d3-4e065db638492024-06-24WarningsName fallback
generic name: OCTINOXATE
Giorgio Armani Power Fabric Plus Weightless Matte Foundation Broad Spectrum SPF 25 SunscreenOCTINOXATEL'Oreal USA Products Inc.1b851e19-add0-437b-86e4-e88a10a1e7742024-06-24WarningsName fallback
generic name: OCTINOXATE
Lancome Paris Absolue Bx Makeup Broad Spectrum SPF 18 Sunscreen Absolute Replenishing Radiant Makeup Normal to Dry SkinOCTINOXATEL'Oreal USA Products Inca45fef28-5dde-48b2-b7c0-ede694f4c32b2023-12-30WarningsName fallback
generic name: OCTINOXATE
LOreal Paris True Match Lumi Healthy Luminous Makeup Broad Spectrum SPF 20OCTINOXATEL'Oreal USA Products Inccf39375c-de44-47de-bf15-fce4dfad8c742023-12-29WarningsName fallback
generic name: OCTINOXATE
LOreal Paris Infallible ProGlow Broad Spectrum SPF 15 SunscreenOCTINOXATEL'Oreal USA Products Inc82a6fbba-f0d4-475f-9ba7-615118eed70d2023-12-29WarningsName fallback
generic name: OCTINOXATE
Maybelline New York Instant Age Rewind Eraser Treatment Makeup Broad Spectrum SPF 18 SunscreenOCTINOXATEL'Oreal USA Products Incea0609be-eaa9-4b63-9f07-e2cd974e01ba2023-12-28WarningsName fallback
generic name: OCTINOXATE
Maybelline New York Fit Dewy Plus Smooth Normal to Dry Broad Spectrum SPF 18 SunscreenOCTINOXATEL'Oreal USA Products Incb3a37055-b58f-4c42-963b-01c1136f692d2023-12-28WarningsName fallback
generic name: OCTINOXATE

Reported adverse events (FAERS/openFDA)#

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