ZO SKIN HEALTH OCLIPSE SMART TONE BROAD-SPECTRUM SUNSCREEN SPF 50- avobenzone, homosalate, octisalate, and octocrylene lotion

ZO Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50 by

Drug Labeling and Warnings

ZO Skin Health Smart Tone 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]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 3%	Sunscreen
Homosalate 10%	Sunscreen
Octisalate 5%	Sunscreen
Octocrylene 10%	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 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 or irritation develops and lasts

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 and as needed
• reapply at least every two hours
• use a water resistant sunscreen if swimming or sweating
• children under 6 months of age: Ask a doctor

Other information

• protect the product in this container from excessive heat and direct sun
• you may report a serious adverse reaction to: 5 Technology Dr. Irvine, CA 92618

Inactive ingredients

Water, Dimethicone, Styrene/Acrylates Copolymer, Butyloctyl Salicylate, Dimethicone/Divinyldimethicone/Silsesquioxane Crosspolymer, Glyceryl Stearate, Mica, Butylene Glycol, PEG-100 Stearate, Steareth-21, Polyamide-5, Acrylates Crosspolymer-4, Titanium Dioxide, Argania Acrylates Crosspolymer-4, Titanium Dioxide, Argania Spinosa Kernel Oil, Dimethicone/Vinyl Dimethicone Crosspolymer, Coco-Glucoside, Cetearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Caprylyl Glycol, Ethylene Brassylate, Steareth-2, Phenoxyethanol, Acrylates/Ammonium Methacrylate Copolymer, Boron Nitride, Polymethyl Methacrylate, Panthenyl Triacetate, Isostearic Acid, Ethyl Linoleate, Fragrance, Hexylene Glycol, Glycerin, Disodium EDTA, Oleyl Alcohol, Melanin, Aluminum Hydroxide, Sodium Hydroxide, Tocopheryl Acetate, Tocopherol, Polyglyceryl-5 Trioleate, Ethyl Ferulate, C12-15 Alkyl Benzoate, Tetrahexyldecyl Ascorbate, Retinyl Palmitate, Ascorbic Acid, Silica Dimethyl Silylate, Petasites Japonicus Root Extract, Disodium Uridine Phosphate, Rosmarinus Officinalis (Rosemary) Leaf Extract, PEG-6 Stearate, Beta-Glucan, Potassium Sorbate, PEG-32, PEG-100, Cyclotetrasiloxane, Pentylene Glycol, Ethylhexylglycerin, Sorbic Acid, Iron Oxides.

SPL UNCLASSIFIED SECTION

DIST BY
ZO Skin Health, Inc. Irvine, CA 92618

PRINCIPAL DISPLAY PANEL - 20 mL Tube Carton

ZO® SKIN HEALTH
BY ZEIN OBAGI MD

NDC: 42851-055-17

OCLIPSE®
SMART TONE
BROAD-SPECTRUM
SUNSCREEN SPF 50

UVA / UVB / HEV / IR-A
PROTECTION

ZOX12™

20 mL / 0.67 Fl. Oz.

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH OCLIPSE SMART TONE BROAD-SPECTRUM SUNSCREEN SPF 50 
avobenzone, homosalate, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-055
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MICA (UNII: V8A1AW0880)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-100 STEARATE (UNII: YD01N1999R)
STEARETH-21 (UNII: 53J3F32P58)
ETHYL GLUTAMATE (UNII: 3EC85NWR4K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ARGAN OIL (UNII: 4V59G5UW9X)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
COCO GLUCOSIDE (UNII: ICS790225B)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
STEARETH-2 (UNII: V56DFE46J5)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BORON NITRIDE (UNII: 2U4T60A6YD)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B)
ISOSTEARIC ACID (UNII: X33R8U0062)
ETHYL LINOLEATE (UNII: MJ2YTT4J8M)
DALTEPARIN SODIUM (UNII: 12M44VTJ7B)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
MELAMINE (UNII: N3GP2YSD88)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TOCOPHEROL (UNII: R0ZB2556P8)
POLYGLYCERYL-10 OLEATE (UNII: 55C81W76DH)
ETHYL FERULATE (UNII: 5B8915UELW)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
PETASITES JAPONICUS ROOT (UNII: 6F650HF10T)
URIDINE MONOPHOSPHATE DISODIUM (UNII: KD8E20071T)
ROSEMARY (UNII: IJ67X351P9)
PEG-6 STEARATE (UNII: 8LQC57C6B0)
CURDLAN (UNII: 6930DL209R)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
POLYETHYLENE GLYCOL 4500 (UNII: TVH7653921)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SORBIC ACID (UNII: X045WJ989B)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-055-45	1 in 1 CARTON	05/01/2015
1		45 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 42851-055-17	1 in 1 CARTON	07/01/2016
2		20 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	part352	04/01/2015

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
Lifetech Resources		622559110	MANUFACTURE(42851-055)