ZO SKIN HEALTH OCLIPSE SUN SPF 50 BROAD SPECTRUM SUNSCREEN SPF 50 FOR FACE PLUS BODY WATER/PERSPIRATION RESISTANT (80 MINUTES) UVA / UVB / HEV / IR-A PROTECTION ZOX12- avobenzone, homosalate, octinoxate, octisalate, and octocrylene aerosol, spray

ZO SKIN HEALTH OCLIPSE SUN SPF 50 BROAD SPECTRUM SUNSCREEN SPF 50 FOR FACE PLUS BODY WATER/PERSPIRATION RESISTANT (80 minutes) UVA / UVB / HEV / IR-A PROTECTION ZOX12 by

Drug Labeling and Warnings

ZO SKIN HEALTH OCLIPSE SUN SPF 50 BROAD SPECTRUM SUNSCREEN SPF 50 FOR FACE PLUS BODY WATER/PERSPIRATION RESISTANT (80 minutes) UVA / UVB / HEV / IR-A PROTECTION ZOX12 by is a Otc medication manufactured, distributed, or labeled by ZO Skin Health, Inc., Product Quest. 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
Octinoxate 5%	Sunscreen
Octisalate 5%	Sunscreen
Octocrylene 10%	Sunscreen

Uses

• helps prevent sunburn
• higher SPF gives more sunburn protection
• retains SPF after 80 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

Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F. Keep out of reach of children.

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

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• children under 6 months of age: ask a doctor
• reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
• 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.
• you may report a serious adverse reaction to:
  5 Technology Dr. Irvine, CA 92618

Inactive ingredients

Water, Cetyl Dimethicone, Aluminum Starch Octenylsuccinate, Alcohol, C12-15 Alkyl Benzoate, Glycerin, Styrene/acrylic copolymer, Neopentyl Glycol Diheptanoate, Polyester-7, Sodium PCA, Polyester-8, Phenoxyethanol, Ethylhexyl Stearate, Steareth-100, Propylene Glycol, Trideceth-6, Lanolin Oil, Cyclopentasiloxane, Helianthus Annuus (Sunflower) Seed Oil, Argania Spinosa Kernel Oil, Caprylyl Glycol, Steareth-2, Polymethyl Methacrylate, Zanthoxylum Bungeanum Fruit Extract, Acrylates/Dimethicone Copolymer, Panthenyl Triacetate, Tocopherol, Ethylhexylglycerin, Oleyl Alcohol, Ethyl Linoleate, Xanthan Gum, Mannan, Disodium EDTA, Cedrus Atlantica Bark Extract, Portulaca Oleracea Extract, Melanin, Isopropyl Alcohol, Bisabolol, Tocopheryl Acetate, Pentylene Glycol, t-Butyl Alcohol, Denatonium Benzoate, 1,2-Hexanediol, Ammonium Hydroxide, Beta-Glucan, Retinyl Palmitate, Ascorbic Acid.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

ZO® SKIN HEALTH
BY ZEIN OBAGI MD

NDC: 42851-057-21

OCLIPSE®
SUN SPRAY SPF 50

BROAD SPECTRUM SUNSCREEN
SPF 50 FOR FACE + BODY

WATER/PERSPIRATION RESISTANT
(80 minutes)

UVA / UVB / HEV / IR-A PROTECTION
ZOX12™

118 mL / 4 Fl. Oz.

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH OCLIPSE SUN SPF 50 BROAD SPECTRUM SUNSCREEN SPF 50 FOR FACE PLUS BODY WATER/PERSPIRATION RESISTANT (80 MINUTES) UVA / UVB / HEV / IR-A PROTECTION ZOX12 
avobenzone, homosalate, octinoxate, octisalate, and octocrylene aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-057
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 g  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 g  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 g  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 g  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETYL DIMETHICONE 45 (UNII: IK315POC44)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
ALCOHOL (UNII: 3K9958V90M)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
POLYESTER-7 (UNII: 0841698D2F)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
STEARETH-100 (UNII: 4OH5W9UM87)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
LANOLIN OIL (UNII: OVV5IIJ58F)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ARGAN OIL (UNII: 4V59G5UW9X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
STEARETH-2 (UNII: V56DFE46J5)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
ZANTHOXYLUM BUNGEANUM FRUIT (UNII: 3CIP16A418)
PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B)
TOCOPHEROL (UNII: R0ZB2556P8)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
ETHYL LINOLEATE (UNII: MJ2YTT4J8M)
XANTHAN GUM (UNII: TTV12P4NEE)
YEAST MANNAN (UNII: 91R887N59P)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CEDRUS ATLANTICA BARK (UNII: ITP1Q41UPF)
PURSLANE (UNII: M6S840WXG5)
MELAMINE (UNII: N3GP2YSD88)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LEVOMENOL (UNII: 24WE03BX2T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CURDLAN (UNII: 6930DL209R)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ASCORBIC ACID (UNII: PQ6CK8PD0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-057-21	1 in 1 CARTON	07/01/2016
1		118 mL in 1 BOTTLE, SPRAY; 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	06/01/2016

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest		927768135	MANUFACTURE(42851-057)