ZO SKIN HEALTH SHEER FLUID BROAD-SPECTRUM SUNSCREEN SPF 50- zinc oxide lotion

ZO Skin Health Sheer Fluid Broad-Spectrum Sunscreen SPF 50 by

Drug Labeling and Warnings

ZO Skin Health Sheer Fluid Broad-Spectrum Sunscreen SPF 50 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 22.0%: 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.
• Use a water-resistant sunscreen if swimming or sweating
  • Reapply: ■ at least every 2 hours ■ 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

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

Inactive Ingredients

Dimethicone, Water, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Cetyl PEG/PPG-10/1 Dimethicone, Silica, Glycerin, Butylene Glycol, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Polysorbate 20, Dimethicone Crosspolymer, Ethyl Ferulate, Triethoxycaprylylsilane, Bisabolol, Phenoxyethanol, Polymethyl Methacrylate, Caprylyl Glycol, Chlorphenesin, Sodium Chloride, Helianthus Annuus (Sunflower) Seed Oil, Sodium Citrate, Melanin, Pentylene Glycol, 1,2-Hexanediol, Ascorbic Acid, Retinyl Palmitate, Beta-Glucan, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol, Ethylhexylglycerin, Iron Oxides.

Principal Display Panel

ZO® Skin Health

by Zein Obagi MD

NDC: 42851-091-50

Sheer Fluid Broad-Spectrum Sunscreen SPF 50

ZOX12®

50 mL / 1.7 Fl. Oz.

Mineral fluid sunscreen with a natural, bare-faced finish for all skin types. Antioxidant-rich formula defends skin against environmental aggressors. Provides broad-spectrum protection against UVA/UVB. Natural melanin shields skin from aging effects of high-energy visible (HEV) light.

Oxybenzone free.

Shake well before dispensing.

ZOX12®

12-hour, time-release ZOX12® complex, our sunscreens help shield the skin from harmful infrared (IR-A) rays.

Dist. by ZO Skin Health, Inc. Irvine, CA 92618 | Made in USA with US & imported materials zoskinhealth.com | 916700

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH SHEER FLUID BROAD-SPECTRUM SUNSCREEN SPF 50 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-091
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.225 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYL FERULATE (UNII: 5B8915UELW)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
TOCOPHEROL (UNII: R0ZB2556P8)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
ARGAN OIL (UNII: 4V59G5UW9X)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
WATER (UNII: 059QF0KO0R)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
LEVOMENOL (UNII: 24WE03BX2T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ROSEMARY (UNII: IJ67X351P9)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIMETHICONE (UNII: 92RU3N3Y1O)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-091-50	1 in 1 CARTON	04/01/2023
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	04/01/2023

Labeler - ZO Skin Health, Inc. (826468527)