FDA.reportPublic FDA data

OCTINOXATE, ZINC OXIDE

Manufacturer
Stila Style, LLC
Effective date
2022-04-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:49:09

Label at a glance#

ProductStay All Day 10-in-1 Illuminating Skin Veil Broad-Spectrum SPF 30 Sunscreen Water-Resistant 80 minutes KITTEN
Active ingredientOCTINOXATE, ZINC OXIDE
Label structure7 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 and as needed • reapply at least every 2 hours • reapply after 80 minutes of swimming or sweating • reapply after towel drying • children under 6 months: Ask a doctor • 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 of 15 or higher an...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 5.0%

Zinc Oxide 18.6%

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.

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

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 and as needed
• reapply at least every 2 hours
• reapply after 80 minutes of swimming or sweating
• reapply after towel drying
• children under 6 months: Ask a doctor
• 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 of 15 or higher and other sun protection measures including:
• limit time in the sun especially from 10am - 2pm
• wear long-sleeved shirts, pants, hats, and sunglasses

Other Information

SPL UNCLASSIFIED SECTION

Protect the product in this container from excessive heat and direct sun.

Inactive ingredients :

INACTIVE INGREDIENT SECTION

WATER/AQUA/EAU, C12-15 ALKYL BENZOATE, HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE, DIMETHICONE CROSSPOLYMER,-
CYCLOPENTASILOXANE, GLYCERIN, ISOPENTYLDIOL, PYRUS MALUS (APPLE) FRUIT EXTRACT, ISODODECANE, DIMETHICONE, MICA, TRIETHOXYCAPRYLYLSILANE, PHENOXYETHANOL, SODIUM CHLORIDE, CAPRYLIC/CAPRIC TRIGLYCERIDE, PHYSALIS ANGULATA EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, DISTEARDIMONIUM HECTORITE, POLYHYDROXYSTEARIC ACID, SILICA, PEG/PPG-18/18 DIMETHICONE, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, HEXYLENE GLYCOL, PROPYLENE CARBONATE, PARFUM, PHYTIC ACID, SODIUM HYDROXIDE, ROSMA R INUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, PALMITOYL TRIPEPTIDE-37, DECARBOXY CARNOSINE HCL, TOCOPHEROL, BUTYLENE GLYCOL, LINALOOL, HEXYL CINNAMAL. (+/-) IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891). <ILN C121042.2>

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package03Outer Package03Inner Package03Inner Package03

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76049-202-302023-07-28C16284748780-10191ceaa-66fe-198a-e063-dbdaa90aec3eStay All Day® 10-in-1 Illuminating Skin Veil Broad-Spectrum SPF 30 Sunscreen Water-Resistant (80 minutes) KITTEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76049-202-30Stay All Day 10-in-1 Illuminating Skin Veil Broad-Spectrum SPF 30 Sunscreen Water-Resistant 80 minutes KITTEN1 in 1 CARTONCREAM11
76049-202-30Stay All Day 10-in-1 Illuminating Skin Veil Broad-Spectrum SPF 30 Sunscreen Water-Resistant 80 minutes KITTEN30 mL in 1 TUBECREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76049-202STAY ALL DAY 10-IN-1 ILLUMINATING SKIN VEIL BROAD-SPECTRUM SPF 30 SUNSCREEN WATER-RESISTANT 80 MINUTES KITTEN (OCTINOXATE, ZINC OXIDE) CREAM [STILA STYLE, LLC]1Legacy NDC, 2 package rows20220412_dc620d3f-8811-df05-e053-2995a90a8409.zip

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76049-20276049-202-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE8TE0BZU36SIACT
CYCLOMETHICONE 50THT5PCI0RIACT
GLYCERINPDC6A3C0OXIACT
ISOPENTYLDIOL19NOL5474QIACT
APPLEB423VGH5S9IACT
ISODODECANEA8289P68Y2IACT
DIMETHICONE92RU3N3Y1OIACT
MICAV8A1AW0880IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM CHLORIDE451W47IQ8XIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PHYSALIS ANGULATA WHOLEW4TKW9D5GGIACT
SUNFLOWER OIL3W1JG795YIIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
PEG/PPG-18/18 DIMETHICONE9H0AO7T794IACT
CAPRYLYL GLYCOL00YIU5438UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
PROPYLENE CARBONATE8D08K3S51EIACT
FYTIC ACID7IGF0S7R8IIACT
SODIUM HYDROXIDE55X04QC32IIACT
ROSEMARYIJ67X351P9IACT
DECARBOXY CARNOSINE HYDROCHLORIDE6X7K9I5QR7IACT
TOCOPHEROLR0ZB2556P8IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
LINALOOL, (+/-)-D81QY6I88EIACT
CINNAMALDEHYDESR60A3XG0FIACT
FERRIC OXIDE RED1K09F3G675IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
OCTINOXATE4Y5P7MUD51ACTIB
ZINC OXIDESOI2LOH54ZACTIM

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
dc620d3f-8812-df05-e053-2995a90a8409dc620d3f-8811-df05-e053-2995a90a84092022-04-11WarningsExact identifier
spl id: dc620d3f-8812-df05-e053-2995a90a8409
spl set id: dc620d3f-8811-df05-e053-2995a90a8409

Reported adverse events (FAERS/openFDA)#

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