FDA.reportPublic FDA data

AVOBENZONE, HOMOSALATE, OCTISALATE, and OCTOCRYLENE

Manufacturer
ZO Skin Health, Inc. | Product Quest
Effective date
2016-03-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:27:32

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, 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: 1 Technology Dr. B123, 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 15%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

Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120ºF.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

SPL UNCLASSIFIED SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash or irritation develops and lasts

OTC - KEEP OUT OF REACH OF CHILDREN 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:
    1 Technology Dr. B123, Irvine, CA 92618

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Cetyl Dimethicone, Aluminum Starch Octenylsuccinate, SD Alcohol 40, C12-15 Alkyl Benzoate, Glycerin, Styrene/Acrylates Copolymer, Polyester-7, Neopentyl Glycol Diheptanoate, Steareth-100, Steareth-2, Mannan, Xanthan Gum, Polyester-8, Ethylhexylglycerin, Phenoxyethanol, Sodium PCA, Ethylhexyl Stearate, Argania Spinosa Kernel Oil, Beta-Glucan, Cyclopentasiloxane, Acrylates/Dimethicone Copolymer, Propylene Glycol, Trideceth-6, C10-30 Cholesterol/Lanosterol Esters, Caprylyl Glycol, Melanin, Panthenyl Triacetate, Ethyl Linoleate, Oleyl Alcohol, Tocopherol, Polymethyl Methacrylate, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Zanthoxylum Bungeanum Fruit Extract, Cedrus Atlantica Bark Extract, Portulaca Oleracea Extract, Disodium EDTA, Bisabolol.

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 42851-054-21

OCLIPSE®
SUN SPRAY SPF 50
BROAD SPECTRUM SUNSCREEN
SPF 50 FOR FACE + BODY
WATER/PERSPIRATION RESISTANT
(80 minutes)

118 mL / 4 Fl. Oz.

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42851-054-212023-03-27C16284748780-1ab0e2407-29f1-f274-e053-dbdaa90a6471ZO ® SKIN HEALTH OCLIPSE ® SUN SPRAY SPF 50 BROAD SPECTRUM SUNSCREEN SPF 50 FOR FACE + BODY WATER/PERSPIRATION RESISTANT (80 minutes)
42851-054-212020-09-27C16284748780-1ab0e2407-29f1-f274-e053-dbdaa90a6471ZO ® SKIN HEALTH OCLIPSE ® SUN SPRAY SPF 50 BROAD SPECTRUM SUNSCREEN SPF 50 FOR FACE + BODY WATER/PERSPIRATION RESISTANT (80 minutes)
42851-054-212020-09-25C16284748780-1ab0e2407-29f1-f274-e053-dbdaa90a6471ZO ® SKIN HEALTH OCLIPSE ® SUN SPRAY SPF 50 BROAD SPECTRUM SUNSCREEN SPF 50 FOR FACE + BODY WATER/PERSPIRATION RESISTANT (80 minutes)
42851-054-212020-07-22C16284748780-1ab0e2407-29f1-f274-e053-dbdaa90a6471ZO ® SKIN HEALTH OCLIPSE ® SUN SPRAY SPF 50 BROAD SPECTRUM SUNSCREEN SPF 50 FOR FACE + BODY WATER/PERSPIRATION RESISTANT (80 minutes)

Products#

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

DailyMed product names page 1 of 2 · 44 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42851-05442851-054-21

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
CETYL DIMETHICONE 45IK315POC44IACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
ALCOHOL3K9958V90MIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GLYCERINPDC6A3C0OXIACT
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)5Z4DPO246AIACT
POLYESTER-70841698D2FIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
STEARETH-1004OH5W9UM87IACT
STEARETH-2V56DFE46J5IACT
YEAST MANNAN91R887N59PIACT
XANTHAN GUMTTV12P4NEEIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
ETHYLHEXYL STEARATEEG3PA2K3K5IACT
ARGAN OIL4V59G5UW9XIACT
CURDLAN6930DL209RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TRIDECETH-63T5PCR2H0CIACT
C10-30 CHOLESTEROL/LANOSTEROL ESTERS137SL7IL0YIACT
CAPRYLYL GLYCOL00YIU5438UIACT
MELAMINEN3GP2YSD88IACT
PANTHENOL TRIACETATE, (+)-1206E8961BIACT
ETHYL LINOLEATEMJ2YTT4J8MIACT
OLEYL ALCOHOL172F2WN8DVIACT
TOCOPHEROLR0ZB2556P8IACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ASCORBIC ACIDPQ6CK8PD0RIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
ZANTHOXYLUM BUNGEANUM FRUIT3CIP16A418IACT
CEDRUS ATLANTICA BARKITP1Q41UPFIACT
PURSLANEM6S840WXG5IACT

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
f7e930e0-c622-97af-e053-6294a90ac4bec86ee907-d7b1-497d-b3a1-47484bf118b32023-03-27WarningsExact identifier
spl set id: c86ee907-d7b1-497d-b3a1-47484bf118b3

Reported adverse events (FAERS/openFDA)#

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