ZO SKIN HEALTH OCLIPSE DAILY SHEER BROAD-SPECTRUM SUNSCREEN SPF 50- avobenzone, homosalate, octinoxate, octisalate, and octocrylene lotion

ZO SKIN HEALTH OCLIPSE DAILY SHEER BROAD-SPECTRUM SUNSCREEN SPF 50 by

Drug Labeling and Warnings

ZO SKIN HEALTH OCLIPSE DAILY SHEER BROAD-SPECTRUM SUNSCREEN SPF 50 by is a Otc medication manufactured, distributed, or labeled by ZO Skin Health, Inc., Thibiant International, 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
Octinoxate 5%	Sunscreen
Octisalate 5%	Sunscreen
Octocrylene 3%	Sunscreen

Uses

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

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
• 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, Butyloctyl Salicylate, Caprylyl Methicone, Propanediol, Silica, Acrylates Copolymer, PEG-100 Stearate, Glyceryl Stearate, Cetearyl Alcohol, Styrene/Acrylates Copolymer, Polymethyl Methacrylate, Glycerin, Maltodextrin, Isododecane, Phenoxyethanol, Lanolin Oil, Acrylates/Dimethicone Copolymer, Helianthus Annuus (Sunflower) Seed Oil, Cetearyl Glucoside, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Squalane, Ethylhexylglycerin, Pentylene Glycol, PEG-8 Laurate, Fragrance, Stachys Officinalis Flower/Leaf/Stem Extract, Disodium EDTA, Tocopheryl Acetate, Polysorbate 60, Sodium Hydroxide, Citric Acid, Melanin, Sorbitan Isostearate, Polyglyceryl-5 Trioleate, Ethyl Ferulate, Retinyl Palmitate, Ascorbic Acid, 1,2-Hexanediol, BHT, Rosmarinus Officinalis (Rosemary) Leaf Extract, Beta-Glucan, Tocopherol, Disodium Uridine Phosphate.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 45 mL Tube Carton

ZO® SKIN HEALTH
BY ZEIN OBAGI MD

NDC: 42851-059-45

OCLIPSE®
DAILY SHEER

BROAD-SPECTRUM
SUNSCREEN SPF 50

WATER/PERSPIRATION
RESISTANT (80 minutes)

UVA/UVB/HEV/IR-A
PROTECTION

ZOX12™

45 mL / 1.5 Fl. Oz.

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH OCLIPSE DAILY SHEER BROAD-SPECTRUM SUNSCREEN SPF 50 
avobenzone, homosalate, octinoxate, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-059
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
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	50 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Caprylyl Trisiloxane (UNII: Q95M2P1KJL)
Propanediol (UNII: 5965N8W85T)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
PEG-100 Stearate (UNII: YD01N1999R)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
Glycerin (UNII: PDC6A3C0OX)
Maltodextrin (UNII: 7CVR7L4A2D)
Isododecane (UNII: A8289P68Y2)
Phenoxyethanol (UNII: HIE492ZZ3T)
Lanolin Oil (UNII: OVV5IIJ58F)
Sunflower Oil (UNII: 3W1JG795YI)
Cetearyl Glucoside (UNII: 09FUA47KNA)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
Squalane (UNII: GW89575KF9)
Ethylhexylglycerin (UNII: 147D247K3P)
Pentylene Glycol (UNII: 50C1307PZG)
PEG-8 Laurate (UNII: 762O8IWA10)
Stachys Officinalis Flowering Top (UNII: D7A759WU38)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Polysorbate 60 (UNII: CAL22UVI4M)
Sodium Hydroxide (UNII: 55X04QC32I)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44)
Sorbitan Isostearate (UNII: 01S2G2C1E4)
Ethyl Ferulate (UNII: 5B8915UELW)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Ascorbic Acid (UNII: PQ6CK8PD0R)
1,2-Hexanediol (UNII: TR046Y3K1G)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
Rosemary (UNII: IJ67X351P9)
Tocopherol (UNII: R0ZB2556P8)
Uridine Monophosphate Disodium (UNII: KD8E20071T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-059-45	1 in 1 CARTON	11/01/2016
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	part352	11/01/2016

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
Thibiant International, Inc.		083913913	MANUFACTURE(42851-059)