SUNSCREEN PLUS POWDER BROAD-SPECTRUM SPF 45- zinc oxide powder

Sunscreen Plus Powder Broad-Spectrum SPF 45 by

Drug Labeling and Warnings

Sunscreen Plus Powder Broad-Spectrum SPF 45 by is a Otc medication manufactured, distributed, or labeled by ZO Skin Health, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

• Active Ingredients: Purpose
• Zinc Oxide 25.0%: Sunscreen

Purpose   Sunscreen

Uses

• Helps prevent sunburn
• Higher SPF gives more sunburn protection
• Provides high protection against 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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure
• Reapply: at least every 2 hours
• Use a water-resistant sunscreen if swimming or sweating
• Children under 6 months of age: Ask a doctor
• 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 value 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-sleeved shirts, pants, hats, and sunglasses.

Other Information

• Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

• Protect the product in this container from excessive heat and direct sun.

• You may report a serious adverse reaction to: 9685 Research Dr., Irvine, CA 92618

Inactive Ingredients

HDI/Trimethylol Hexyllactone Crosspolymer, Simmondsia Chinensis (Jojoba) Butter, Bronze Powder, Simmondsia Chinensis
(Jojoba) Seed Oil, Triethoxycaprylylsilane, Bisabolol, Ethyl Ferulate, Ethylhexylglycerin, Melanin, Pentylene Glycol, Water, Silica, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Phenoxyethanol.

SPL UNCLASSIFIED SECTION

Dist. by ZO Skin Health, Inc. Irvine, CA 92618 Made in USA with US & imported materials zoskinhealth.com | 972300

Principal Display Panel

ZO® SKIN HEALTH

BY ZEIN OBAGI MD

NDC: 42851-069-27

SUNSCREEN + POWDER BROAD-SPECTRUM SPF 45

ZOX12®

DEEP

Net Wt. 2.7 g / 0.09 Oz.

INGREDIENTS AND APPEARANCE

SUNSCREEN PLUS POWDER BROAD-SPECTRUM SPF 45 
zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-069
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.675 mg  in 2.7 g

Inactive Ingredients
Ingredient Name	Strength
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
JOJOBA BUTTER (UNII: XIA46H803R)
COPPER (UNII: 789U1901C5)
JOJOBA OIL (UNII: 724GKU717M)
ETHYL FERULATE (UNII: 5B8915UELW)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
LEVOMENOL (UNII: 24WE03BX2T)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-069-27	1 in 1 CARTON	02/09/2021
1		2.7 g in 1 JAR; 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	02/09/2021

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
Bentley Laboratories, LLC		068351753	manufacture(42851-069)