FDA.reportPublic FDA data

AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, and OCTOCRYLENE

Manufacturer
ZO Skin Health, Inc. | Product Quest
Effective date
2016-04-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:26:25

Label at a glance#

ProductZO SKIN HEALTH OCLIPSE SUN SPF 50 BROAD SPECTRUM SUNSCREEN SPF 50 FOR FACE PLUS BODY WATER/PERSPIRATION RESISTANT (80...
Active ingredientAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE
Label structure9 sections

Indications and 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

Dosage and administration

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 pro...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Avobenzone 3%Sunscreen
Homosalate 10%Sunscreen
Octinoxate 5%Sunscreen
Octisalate 5%Sunscreen
Octocrylene 10%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - DO NOT USE SECTION

Do not use

  • on damaged or broken skin

OTC - WHEN USING SECTION

When using this product

  • keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • rash or irritation develops and lasts

SPL UNCLASSIFIED SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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.

Principal Display Panel - 118 mL Bottle Carton
Principal Display Panel - 118 mL Bottle Carton

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 50 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42851-05742851-057-21

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 48 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
CETYL DIMETHICONE 45IK315POC44IACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
ALCOHOL3K9958V90MIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GLYCERINPDC6A3C0OXIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
POLYESTER-70841698D2FIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
STEARETH-1004OH5W9UM87IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TRIDECETH-63T5PCR2H0CIACT
LANOLIN OILOVV5IIJ58FIACT
CYCLOMETHICONE 50THT5PCI0RIACT
SUNFLOWER OIL3W1JG795YIIACT
ARGAN OIL4V59G5UW9XIACT
CAPRYLYL GLYCOL00YIU5438UIACT
STEARETH-2V56DFE46J5IACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
ZANTHOXYLUM BUNGEANUM FRUIT3CIP16A418IACT
PANTHENOL TRIACETATE, (+)-1206E8961BIACT
TOCOPHEROLR0ZB2556P8IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
OLEYL ALCOHOL172F2WN8DVIACT
ETHYL LINOLEATEMJ2YTT4J8MIACT
XANTHAN GUMTTV12P4NEEIACT
YEAST MANNAN91R887N59PIACT
EDETATE DISODIUM7FLD91C86KIACT
CEDRUS ATLANTICA BARKITP1Q41UPFIACT
PURSLANEM6S840WXG5IACT
MELAMINEN3GP2YSD88IACT
ISOPROPYL ALCOHOLND2M416302IACT
LEVOMENOL24WE03BX2TIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a8387c38-893e-6529-e053-2995a90a28485459fb25-eed7-46c1-9e31-8db618c2adbb2020-07-13WarningsExact identifier
spl set id: 5459fb25-eed7-46c1-9e31-8db618c2adbb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.