FDA.reportPublic FDA data

ZO Skin Health ZO Favorites (Mothers Day GWP)

Manufacturer
ZO Skin Health, Inc. | Lifetech Resources, LLC. | Thibiant International, Inc. | PakLab
Effective date
2020-06-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:18:13

Label at a glance#

ProductZO Skin Health ZO Favorites (Mothers Day GWP)
Active ingredientTITANIUM DIOXIDE
Label structure10 sections

Indications and uses

helps prevent sunburn. 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 use a water resistant sunscreen if swimming or sweating children under 6 months of age: ask a doctor reapply at least every two 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 measure...

Storage and handling

protect this product 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

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 8.2%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn.
  • 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

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

  • if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • children under 6 months of age: ask a doctor
  • reapply at least every two 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 this product 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

Cyclopentasiloxane, Dimethicone Crosspolymer, Phenyl Trimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Dimethiconol, Aluminum Hydroxide, Stearic Acid, Dimethicone/Vinyl Dimethicone Crosspolymer, Tribehenin, Helianthus Annuus Seed Oil, Polymethyl Methacrylate, Water, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Polyglyceryl-4 Isostearate, Glycerin, Glycine Soja Seed Extract, Caprylic/Capric Triglyceride, Behenyl Behenate, Squalane, Tocopheryl Acetate, Melanin, Ethyl Ferulate, Polyglyceryl-5 Trioleate, Triethoxycaprylylsilane, Ascorbic Acid, Methylisothiazolinone, Retinyl Palmitate, Pentylene Glycol, Rosmarinus Officinalis Leaf Extract, Ethylhexylglycerin, Disodium Uridine Phosphate, Tocopherol, Myristoyl Pentapeptide-8, Iron Oxides.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZO ® SKIN HEALTH
BY ZEIN OBAGI, MD

NDC 42851-162-01

ZO ★ FAVORITES

OFFECTS ® EXFOLIATING CLEANSER
40 mL / 1.5 Fl. Oz.
OSSENTIAL ® DAILY POWER DEFENSE
30 mL / 1 Fl. Oz.
OCLIPSE ® SUNSCREEN + PRIMER SPF 30
15 mL / 0.5 Fl. Oz.

PRINCIPAL DISPLAY PANEL - Kit Carton
PRINCIPAL DISPLAY PANEL - Kit Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42851-162-012021-07-23C16284748780-1c7ccaba7-1b9c-fd44-e053-dadaa90aa01bZO ® Skin Health ZO ® Favorites (Mother's Day GWP) NDC 42851-162

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42851-053-01ZO Skin Health ZO Favorites (Mothers Day GWP)15 mL in 1 BOTTLE, PUMPLOTION15 mL82 mg in 1mL2
42851-162-01ZO Skin Health ZO Favorites (Mothers Day GWP)1 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42851-053ZO SKIN HEALTH ZO FAVORITES (MOTHERS DAY GWP) (TITANIUM DIOXIDE) KIT [ZO SKIN HEALTH, INC.]2Legacy NDC20200618_f0511ded-4e60-4924-812b-c4f32c1065ab.zip
42851-162ZO SKIN HEALTH ZO FAVORITES (MOTHERS DAY GWP) (TITANIUM DIOXIDE) KIT [ZO SKIN HEALTH, INC.]2Legacy NDC, 2 package rows20200618_f0511ded-4e60-4924-812b-c4f32c1065ab.zip

Products#

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

DailyMed product names page 1 of 3 · 91 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42851-16242851-162-01
42851-05342851-053-01

Ingredients#

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

DailyMed ingredient rows page 1 of 3 · 105 matching rows.

Name, UNII, Kind table
NameUNIIKind
TEA TREE OILVIF565UC2GINGR
WATER059QF0KO0RINGR
SODIUM LAURETH-3 SULFATEBPV390UAP0INGR
COCAMIDOPROPYL BETAINE5OCF3O11KXINGR
HIGH DENSITY POLYETHYLENEUG00KM4WR7INGR
GLYCERINPDC6A3C0OXINGR
COCAMIDOPROPYL HYDROXYSULTAINE62V75NI93WINGR
DISODIUM COCOAMPHODIACETATE18L9G3U51MINGR
MANNITOL3OWL53L36AINGR
POWDERED CELLULOSESMD1X3XO9MINGR
SODIUM HYDROXIDE55X04QC32IINGR
BUTYLENE GLYCOL3XUS85K0RAINGR
FILIPENDULA ULMARIA ROOT997724QNDSINGR
SALICYLIC ACIDO414PZ4LPZINGR
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2INGR
NIACIN2679MF687AINGR
NIACINAMIDE25X51I8RD4INGR
AMMONIUM LACTATE67M901L9NQINGR
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0INGR
HYPROMELLOSES3NXW29V3WOINGR
BIOSACCHARIDE GUM-1BB4PU4V09HINGR
EDETATE DISODIUM7FLD91C86KINGR
SODIUM CHLORIDE451W47IQ8XINGR
SODIUM CARBONATE45P3261C7TINGR
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNINGR
METHYLISOTHIAZOLINONE229D0E1QFAINGR
MAGNESIUM CHLORIDE02F3473H9OINGR
MAGNESIUM NITRATE77CBG3UN78INGR
LIMONENE, (+)-GFD7C86Q1WINGR
CHROMIUM HYDROXIDE GREENRV8FT8XF5RINGR
WATER059QF0KO0RINGR
CETEARYL ISONONANOATEP5O01U99NIINGR
CYCLOMETHICONE 50THT5PCI0RINGR
CYCLOMETHICONE 6XHK3U310BAINGR
PENTYLENE GLYCOL50C1307PZGINGR
CETOSTEARYL ALCOHOL2DMT128M1SINGR
GLYCERINPDC6A3C0OXINGR
STEARETH-20L0Q8IK9E08INGR
CARBOXYPOLYMETHYLENE0A5MM307FCINGR
C14-22 ALCOHOLSB1K89384RJINGR

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
a83c599c-97e9-e4dc-e053-2995a90a757bf0511ded-4e60-4924-812b-c4f32c1065ab2020-06-16WarningsExact identifier
spl id: a83c599c-97e9-e4dc-e053-2995a90a757b
spl set id: f0511ded-4e60-4924-812b-c4f32c1065ab

Reported adverse events (FAERS/openFDA)#

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