SPF LIP COLOUR- zinc oxide lipstick

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

Active Ingredients

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

Purpose

Sunscreen

Uses

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

Directions

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

Warnings

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.

Keep out of reach of children.

Inactive Ingredients

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

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)

INGREDIENTS AND APPEARANCE

SPF LIP COLOUR 
zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87132-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.3676 g  in 1.8 g

Inactive Ingredients
Ingredient Name	Strength
AVOCADO SEED BUTTER (UNII: TSD0N1V8MB)
CI 77491 (UNII: 1K09F3G675)
COCONUT OIL (UNII: Q9L0O73W7L)
ORANGE OIL (UNII: AKN3KSD11B)
LIME OIL (UNII: UZH29XGA8G)
SHEA BUTTER (UNII: K49155WL9Y)
RASPBERRY (UNII: 4N14V5R27W)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
JOJOBA OIL (UNII: 724GKU717M)
CI 77492 (UNII: EX438O2MRT)
STEVIA LEAF (UNII: 6TC6NN0876)
OLIVE OIL (UNII: 6UYK2W1W1E)
CASTOR OIL (UNII: D5340Y2I9G)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)
BEESWAX (UNII: 2ZA36H0S2V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87132-200-01	1.8 g in 1 TUBE; Type 0: Not a Combination Product	04/30/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/30/2026

Labeler - Lauren Brooke Cosmetiques, LLC (019660169)

Registrant - Lauren Brooke (019660169)

Establishment
Name	Address	ID/FEI	Business Operations
Lauren Brooke Cosmetiques, LLC		019660169	manufacture(87132-200)