ILLUMINOUS TINTED MINERAL SUNSCREEN- zinc oxide cream

Drug Labeling and Warnings

Drug Details [pdf]

Drug Facts

Active Ingredient. . . . . . . . . . . . . . Purpose

Non-nano Zinc Oxide 37.29 %. . . Sunscreen

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 caused by the sun.

Directions

Apply liberally 15 minutes before sun exposure. Reapply every 2 hours & after swimming and towel-drying.

Warnings

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

Keep out of reach of Children

Keep out of reach of Children.

Inactive Ingredients

Organic Capryllc/Capric Triglycerides (Fractionated Coconut) Oil, Certified Organic Cera Alba (Beeswax), Certified Organic Simmondsia Chinensis (Jojoba) Oil, All Natural Silica, All Natural Clay, Certified Organic Camellia Sinensis (Green Tea) Leaf Extract,, Certified Organic Vitamin E (Sunflower-derived) Oil (+/- Naturally Derived Iron Oxides, Naturally Derived Mica, Certified Organic Essential Oil Blend, Melia Azadirachta Seed (Neem) Oil.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ILLUMINOUS TINTED MINERAL SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87132-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	11.18 g  in 30 g

Inactive Ingredients
Ingredient Name	Strength
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
MELIA AZADIRACHTA SEED OIL (UNII: 4DKJ9B3K2T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CITRUS AURANTIFOLIA (LIME) OIL (UNII: UZH29XGA8G)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
KAOLIN (UNII: 24H4NWX5CO)
BEESWAX (UNII: 2ZA36H0S2V)
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87132-100-01	30 g in 1 TUBE; Type 0: Not a Combination Product	09/30/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/30/2025

Labeler - Lauren Brooke Cosmetiques LLC (019660169)

Registrant - Lauren Brooke (019660169)

Establishment
Name	Address	ID/FEI	Business Operations
Lauren Brooke Cosmetiques LLC		019660169	manufacture(87132-100)