ZO SKIN HEALTH GEL SUNSCREEN BROAD-SPECTRUM SPF 50- avobenzone, octisalate, octocrylene gel

ZO Skin Health Gel Sunscreen Broad-Spectrum SPF 50 by

Drug Labeling and Warnings

ZO Skin Health Gel Sunscreen Broad-Spectrum 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
• Avobenzone 3.0%.........: Sunscreen
• Octisalate 5.0%............: Sunscreen
• Octocrylene 10.0%: 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.
• 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

Isododecane, Silica, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Polyamide-8, Polyester-8, Isodecyl Neopentanoate, Polyamide-3, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Polymethylsilsesquioxane/Trimethylsiloxysilicate, Diethylhexyl 2,6-Naphthalate, Diisopropyl Sebacate, Lauryl Lactate, Hydrogenated Poly(C6-20 Olefin), Bisabolol, Lupinus Albus Seed Oil, Triticum Vulgare (Wheat) Germ Extract, Glycine Soja (Soybean) Oil, Leontopodium Alpinum Meristem Cell Culture, Marrubium Vulgare Meristem Cell Culture, Tocopherol, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Melanin, Pentylene Glycol, Lecithin, Caprylyl Glycol, Glycerin, Diethylhexyl Syringylidenemalonate, HDI/Trimethylol Hexyllactone Crosspolymer, Polymethyl Methacrylate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Water, Ethylhexylglycerin.

Principal Display Panel

ZO® Skin Health Gel Sunscreen Broad-Spectrum SPF 50

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.

A clear and unscented gel sunscreen with a complexion smoothing finish for all skin types. Exclusive antioxidant + plant stem cell complexes minimize the aging effects of environmental aggressors. Provides broad-spectrum protection against UVA/UVB. Natural melanin shields skin from aging effects of high-energy visible (HEV) light. Oxybenzone free.

Dist. by ZO Skin Health, Inc. Irvine, CA 92618

Made in USA with US & imported materials

zoskinhealth.com

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH GEL SUNSCREEN BROAD-SPECTRUM SPF 50 
avobenzone, octisalate, octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-092
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.5 g  in 45 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.35 g  in 45 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.25 g  in 45 g

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ISODODECANE (UNII: A8289P68Y2)
POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
WATER (UNII: 059QF0KO0R)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
TOCOPHEROL (UNII: R0ZB2556P8)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
WHEAT GERM (UNII: YR3G369F5A)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
GLYCERIN (UNII: PDC6A3C0OX)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
POLYAMIDE-3 (12000 MW) (UNII: L7P3YWF22X)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATE (UNII: X2PZH4Y6HT)
LAURYL LACTATE (UNII: G5SU0BFK7O)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
LUPINUS ALBUS SEED OIL (UNII: 958BJW095Q)
SOYBEAN OIL (UNII: 241ATL177A)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYDROGENATED C6-20 POLYOLEFIN (100 CST) (UNII: 39EYQ1W9RB)
LEVOMENOL (UNII: 24WE03BX2T)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-092-45	1 in 1 CARTON	04/01/2023
1		45 g 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	04/01/2023

Labeler - ZO Skin Health, Inc. (826468527)