ZO SKIN HEALTH DAILY SHEER BROAD-SPECTRUM SUNSCREEN SPF 45- avobenzone, homosalate, octisalate, octocrylene lotion

ZO Skin Health Daily Sheer Broad-Spectrum Sunscreen SPF 45 by

Drug Labeling and Warnings

ZO Skin Health Daily Sheer Broad-Spectrum Sunscreen 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
• 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

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.

Warnings

For external use only.

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 the product in this container 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, Glyceryl Stearate, PEG-100 Stearate, Tocopheryl Acetate, 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: 42851-094-45

DAILY SHEER BROAD-SPECTRUM SUNSCREEN SPF 45 WATER RESISTANT
(40 Minutes)

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

Non-greasy, quick-drying sunscreen with a sheer matte finish offering broad-spectrum protection against UVA/UVB rays. Natural melanin shields skin from aging effects of high-energy visible (HEV) light. Water and perspiration resistant, this sunscreen delivers superior protection during outdoor activities while hydrating the skin to prevent dryness.
Oxybenzone free.

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

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH DAILY SHEER BROAD-SPECTRUM SUNSCREEN SPF 45 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-094
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
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1350 mg  in 45 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2250 mg  in 45 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4500 mg  in 45 mL

Inactive Ingredients
Ingredient Name	Strength
LEVOMENOL (UNII: 24WE03BX2T)
ROSEMARY (UNII: IJ67X351P9)
DIMETHICONE 100 (UNII: RO266O364U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ETHYL FERULATE (UNII: 5B8915UELW)
ISODODECANE (UNII: A8289P68Y2)
ARGAN OIL (UNII: 4V59G5UW9X)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PEG-100 STEARATE (UNII: YD01N1999R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
STEARETH-21 (UNII: 53J3F32P58)
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
STEARETH-2 (UNII: V56DFE46J5)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SQUALANE (UNII: GW89575KF9)
TOCOPHEROL (UNII: R0ZB2556P8)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-094-45	1 in 1 CARTON	08/01/2023
1		40 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	08/01/2023

Labeler - ZO Skin Health, Inc. (826468527)