VEIL MINERAL PRIMER SUNSCREEN BROAD SPECTRUM SPF 15- zinc oxide and titanium dioxide lotion

VEIL MINERAL PRIMER SUNSCREEN BROAD SPECTRUM SPF 15 by

Drug Labeling and Warnings

VEIL MINERAL PRIMER SUNSCREEN BROAD SPECTRUM SPF 15 by is a Otc medication manufactured, distributed, or labeled by Kingdom Animalia, LLC DBA Hourglass Cosmetics, DELICATE COSMETICS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Zinc Oxide 4.20%

Titanium Dioxide 2.45%

Purpose

Sunscreen

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.

Warnings

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs.

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

Directions

• Apply liberally 15 minutes before sun exposure.
• Use a water resistant sunscreen if swimming or sweating.
• Reapply at least every 2 hours.
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m.—2 p.m.
  • wear long-sleeve shirts, pants, hats and sunglasses.
• Children under 6 months: Ask a doctor.

Inactive Ingredients

CYCLOPENTASILOXANE, ISODODECANE, POLYSILICONE-11, POLYMETHYLSILSES-QUIOXANE, PEG-10 DIMETHICONE, HEXYL LAURATE, POLYGLYCERYL-4 ISOSTEARATE, ALUMINA, STEARIC ACID

Other Information

Protect this product from excessive heat and direct sun.

Questions or comments?

Contact:

CS@hourglasscosmetics.com for more information.

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton

VEIL

MINERAL PRIMER
SUNSCREEN BROAD SPECTRUM SPF 15

HOURGLASS

NET
1 FL OZ / 30 mL

INGREDIENTS AND APPEARANCE

VEIL MINERAL PRIMER SUNSCREEN BROAD SPECTRUM SPF 15 
zinc oxide and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42627-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.2 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.45 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ALUMINUM OXIDE (UNII: LMI26O6933)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42627-101-01	1 in 1 CARTON	09/23/2017
1		30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 42627-101-02	1 in 1 CARTON	09/23/2017
2		60 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 42627-101-03	1 in 1 CARTON	09/23/2017
3		8.9 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	09/23/2017

Labeler - Kingdom Animalia, LLC DBA Hourglass Cosmetics (004924553)

Establishment
Name	Address	ID/FEI	Business Operations
DELICATE COSMETICS INC		137997602	MANUFACTURE(42627-101)