ZO SKIN HEALTH DAILY SHEER BROAD-SPECTRUM SUNSCREEN SPF 50 WATER RESISTANT (40 MINUTES)- avobenzone, homosalate, octisalate, octocrylene cream

ZO Skin Health Daily Sheer Broad-Spectrum Sunscreen SPF 50 Water Resistant (40 Minutes) by

Drug Labeling and Warnings

ZO Skin Health Daily Sheer Broad-Spectrum Sunscreen SPF 50 Water Resistant (40 Minutes) 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
• Avobenzone 3.0%.............: Sunscreen
• Homosalate 6.8% .............: Sunscreen
• Octisalate 5.0%................: Sunscreen
• Octocrylene 10.0% ...........: Sunscreen

Uses

■ helps prevent sunburn
■ higher SPF gives more sunburn protection
■ provides high protection against sunburn
■ retains SPF after 40 minutes of perspiring
■ 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 ■ after 40 minutes of 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

■ Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water, Butyloctyl Salicylate, Silica, Dimethicone, Cetearyl Alcohol, Diethylhexyl 2,6-Naphthalate, Triacontanyl PVP, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Glyceryl Stearate, PEG-100 Stearate, Isododecane, Glycerin, Bisabolol, Propanediol, Steareth-21, Helianthus Annuus (Sunflower) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol, Ascorbic Acid, Retinyl Palmitate, Dipotassium Glycyrrhizate, Squalane, Beta-Glucan, Melanin, Cetearyl Glucoside, Steareth-2, Polysorbate 60, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates Copolymer, Polymethyl Methacrylate, Disodium EDTA, Ethyl Ferulate, Sodium C14-16 Olefin Sulfonate, Sodium Hydroxide, Phenoxyethanol, Ethylhexylglycerin, Pentylene Glycol, 1,2-Hexanediol, Fragrance, Iron Oxides.

Principal Display Panel

ZO® Skin Health

by Zein Obagi MD

NDC: 42851-095-45

Daily Sheer Broad-Spectrum Sunscreen SPF 50

Water Resistant

(40 Minutes)

ZOX12®

45 mL / 1.5 Fl. Oz.

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH DAILY SHEER BROAD-SPECTRUM SUNSCREEN SPF 50 WATER RESISTANT (40 MINUTES) 
avobenzone, homosalate, octisalate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-095
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	3060 mg  in 45 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4500 mg  in 45 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2250 mg  in 45 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1350 mg  in 45 mL

Inactive Ingredients
Ingredient Name	Strength
PENTYLENE GLYCOL (UNII: 50C1307PZG)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIACONTANYL PVP (WP-660) (UNII: N0SS3Q238D)
ARGAN OIL (UNII: 4V59G5UW9X)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERIN (UNII: PDC6A3C0OX)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
SQUALANE (UNII: GW89575KF9)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
STEARETH-2 (UNII: V56DFE46J5)
POLYSORBATE 60 (UNII: CAL22UVI4M)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPANEDIOL (UNII: 5965N8W85T)
ROSEMARY (UNII: IJ67X351P9)
TOCOPHEROL (UNII: R0ZB2556P8)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISODODECANE (UNII: A8289P68Y2)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
ETHYL FERULATE (UNII: 5B8915UELW)
LEVOMENOL (UNII: 24WE03BX2T)
STEARETH-21 (UNII: 53J3F32P58)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-095-45	1 in 1 CARTON	10/01/2023
1		45 mL in 1 TUBE; 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	10/01/2023

Labeler - ZO Skin Health, Inc. (826468527)