FDA.reportPublic FDA data

LipLux Original

Manufacturer
Bell International Laboratories, Inc
Effective date
2017-11-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:10:21

Label at a glance#

ProductLipLux Original SPF 30 Broad Spectrum
Active ingredientOCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE
Label structure9 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 & again after 80 minutes of swimming or sweating. Apply at least ever 2 hours. Sun Protection Measures - to decrease your risk of cancer and early skin aging, regularly use a sunscreen with a broad spectgrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am-2pm and wear long-sleeved shirts, pants, hats, ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%, Octinoxate 7.25%, Octisalate 5.0%, Octocrylene 2.8%

Purpose

OTC - PURPOSE SECTION

Sunscreens

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

Do not use on damaged or broken skin

When using this product keep out of eyes.

Stop use and ask doctor if skin rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure & again after 80 minutes of swimming or sweating. Apply at least ever 2 hours. Sun Protection Measures - to decrease your risk of cancer and early skin aging, regularly use a sunscreen with a broad spectgrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am-2pm and wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months: Ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Ascorbyl Palmitate, Beeswax (ORGANIC), Butyrospermum Parkii (ORGANIC Shea Butter), Carthamus Tinctorius (ORGANIC Safflower) Oil, Cocos Nucifeera (ORGANIC Coconut) Oil, Copernicia Cerifera (ORGANIC Carnauba) Wax, Diethylhexyl 2,6-Naphthalate, Flavor, Glycine Soja (Soybean) Oil, Helianthus Annuus (ORGANIC Sunflower) Seed Oil, Octyldodecanol, Persea Gratissima (ORGANIC Avocado) Oil, Rosa Carnina Fruit Extract (ORGANIC), Rubus Idaeus (Raspberry) Seed Oil, Simmondsia Chinensis (ORGANIC Jojoba) Seed Oil, Tocopherol

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76150-121-142022-12-06C16284748780-1ba0f9c33-411f-a910-e053-dadaa90a0b85COOLA Liplux SPF 30 Lip Balm Original
76150-121-142021-01-29C16284748780-1ba0f9c33-411f-a910-e053-dadaa90a0b85COOLA Liplux SPF 30 Lip Balm Original

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76150-12176150-121-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASCORBYL PALMITATEQN83US2B0NIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
SHEA BUTTERK49155WL9YIACT
CARNAUBA WAXR12CBM0EIZIACT
TOCOPHEROLR0ZB2556P8IACT
YELLOW WAX2ZA36H0S2VIACT
OCTOCRYLENE5A68WGF6WMACTIB
SUNFLOWER OIL3W1JG795YIIACT
SAFFLOWER OIL65UEH262ISIACT
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
AVOBENZONEG63QQF2NOXACTIB
ROSA CANINA FRUIT3TNW8D08V3IACT
SOYBEAN OIL241ATL177AIACT
ALOE VERA LEAFZY81Z83H0XIACT
JOJOBA OIL724GKU717MIACT
AVOCADO OIL6VNO72PFC1IACT
OCTYLDODECANOL461N1O614YIACT
RASPBERRY SEED OIL9S8867952AIACT
COCONUT OILQ9L0O73W7LIACT

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
ef2b42a1-20d2-ed82-e053-2995a90a71615d6bcc7e-0362-6952-e053-2991aa0afe362022-12-06WarningsExact identifier
spl set id: 5d6bcc7e-0362-6952-e053-2991aa0afe36

Reported adverse events (FAERS/openFDA)#

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