FDA.reportPublic FDA data

Drug Facts

Manufacturer
Lauren Brooke Cosmetiques, LLC | Lauren Brooke
Effective date
2026-04-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:57:19

Label at a glance#

ProductSPF Lip Colour
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

Helps prevent sunburn. If used as directed with other sun protection measure decreases the risk of skin cancer and early skin aging.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply every 2 hours & after eating.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Zinc Oxide . . . . . . . . . . 20.4%

Ingredient SectionIngredient Section

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn. If used as directed with other sun protection measure decreases the risk of skin cancer and early skin aging.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Reapply every 2 hours & after eating.

Warnings

WARNINGS SECTION

For external use only. Do not use on damaged or broken skin. Avoid eye contact. Rinse with water to remove. Stop using & ask health practitioner if rash occurs. Keep out of reach of children.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Certified Organic Ricinus Communis (Castor) Oil, Certified Organic Cera Alba (Beeswax), Certified Organic Persea Gratissima (Avocado) Butter, Certified Organic Butyrospermum Parkii (Shea) Butter, All Natural Sustainable Olea Europaea (Olive) Emulsifier, Certified Organic Cocos Nucifera (Coconut) Oil, Certified Organic Olea Europaea (Olive) Oil, Certified Organic Simmondsia Chinensis (Jojoba) Oil, Certified Organic Punica Granatum (Pomegranate) Seed Oil, Certified Organic Vitamin E (Sunflower-derived) Oil, Wildcrafted Stevia, Certified Organic Citrus Sinensis (Sweet Orange) Essential Oil, Certified Organic Rubus Idaeus (Raspberry) Extract, Certified Organic Citrus Aurantifolia (Key Lime) Oil, Certified Organic Punica Granatum (Pomegranate) Extract (+/- Iron Oxides, Mica, Carmine, Manganese Violet)

Inactive Ingredients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Certified Organic Ricinus Communis (Castor) Oil, Certified Organic Cera Alba (Beeswax), Certified Organic Persea Gratissima (Avocado) Butter, Certified Organic Butyrospermum Parkii (Shea) Butter, All Natural Sustainable Olea Europaea (Olive) Emulsifier, Certified Organic Cocos Nucifera (Coconut) Oil, Certified Organic Olea Europaea (Olive) Oil, Certified Organic Simmondsia Chinensis (Jojoba) Oil, Certified Organic Punica Granatum (Pomegranate) Seed Oil, Certified Organic Vitamin E (Sunflower-derived) Oil, Stevia, Certified Organic Citrus Sinensis (Sweet Orange) Essential Oil, Certified Organic Rubus Idaeus (Raspberry) Extract, Certified Organic Citrus Aurantifolia (Key Lime) Oil, Certified Organic Punica Granatum (Pomegranate) Extract (+/- Iron Oxides, Mica, Carmine, Manganese Violet)

Package Label Principal Display LabelPackage Label Principal Display Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87132-200-01SPF Lip Colour1.8 g in 1 TUBELIPSTICK1.81

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87132-20087132-200-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOCADO SEED BUTTERTSD0N1V8MBIACT
CI 774911K09F3G675IACT
COCONUT OILQ9L0O73W7LIACT
ORANGE OILAKN3KSD11BIACT
LIME OILUZH29XGA8GIACT
SHEA BUTTERK49155WL9YIACT
RASPBERRY4N14V5R27WIACT
BROWN IRON OXIDE1N032N7MFOIACT
ZINC OXIDESOI2LOH54ZACTIB
JOJOBA OIL724GKU717MIACT
CI 77492EX438O2MRTIACT
STEVIA LEAF6TC6NN0876IACT
OLIVE OIL6UYK2W1W1EIACT
CASTOR OILD5340Y2I9GIACT
ALPHA-TOCOPHEROLH4N855PNZ1IACT
POMEGRANATE SEED OIL0UI45XV0T6IACT
BEESWAX2ZA36H0S2VIACT

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
SPF Lip ColourZINC OXIDELauren Brooke Cosmetiques, LLC50b344b5-e39d-48ef-e063-6394a90ae41c2026-04-30WarningsExact identifier
ndc (package): 87132-200-01
ndc (product): 87132-200
ndc11 (package): 87132020001
spl id: 50b344b5-e39e-48ef-e063-6394a90ae41c
spl set id: 50b344b5-e39d-48ef-e063-6394a90ae41c

Reported adverse events (FAERS/openFDA)#

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