CREME FOUNDATION- 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

Fractionated Coconut Oil, Organic Cera Alba (Beeswax),Organic Simmondsia Chinensis oil, Silica,Lactobacillus, Organic Argania
Spinosa Oil, Organic Rosa Canina Oil, Clay, Organic Camellia Sinensis Extract, Organic Passiflora Incarnata Extract, Organic Rubus
Idaeus Extract, Organic Melia Azadirachta Oil, Organic Vitamin E Oil, Organic Citrus Tangerina Essential Oil, Organic Citrus Aurantifolia Essential Oil. Iron Oxides.

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INGREDIENTS AND APPEARANCE

CREME FOUNDATION 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87132-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	7.03 g  in 19 g

Inactive Ingredients
Ingredient Name	Strength
CI 77492 (UNII: EX438O2MRT)
CI 77491 (UNII: 1K09F3G675)
RASPBERRY (UNII: 4N14V5R27W)
ARGAN OIL (UNII: 4V59G5UW9X)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
ROSA RUGOSA FLOWER OIL (UNII: X5UY4B2FE4)
PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z)
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)
CI 77007 (UNII: I39WR998BI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87132-500-01	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	01/01/2010

Labeler - Lauren Brooke Cosmetiques LLC (019660169)

Registrant - Lauren Brooke (019660169)

Establishment
Name	Address	ID/FEI	Business Operations
Lauren Brooke Cosmetiques LLC		019660169	manufacture(87132-500)