FDA.reportPublic FDA data

OS-01 Face SPF BS SPF30 Untinted

Manufacturer
ONESKIN INC.
Effective date
2024-09-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:19:33

Label at a glance#

ProductOS-01 Face SPF BS SPF30 Untinted
Active ingredientZINC OXIDE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients – Zinc Oxide 17.5 %

OTC - PURPOSE SECTION

Purpose – Sunscreen

INDICATIONS & USAGE SECTION

Uses –

Helps prevent sunburn
If used as directed with other sun protection measures (See direction), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS SECTION

Warning – 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 eye. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask doctor 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.

DOSAGE & ADMINISTRATION SECTION

Direction-

Apply liberally 15 minutes before sun exposure.
Reapply at least every two hours.
Use a water-resistant sunscreen if swimming or sweating.
Children under 6 months of age: Ask a doctor.
Sun protection measures: spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad-spectrum value of 15 or higher and other sun protection measures including:
Limit time in the sun. especially from 10 am to 2 pm
Wear long-sleeved shirts, pants hats and sunglasses.

OTHER SAFETY INFORMATION

Other information:

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

INACTIVE INGREDIENT SECTION

Inactive ingredients:

Water(aqua), Caprylic/Capric Triglyceride, Glycerin, Methyl Dihydroabietate, Cetearyl Alcohol, Cetyl Palmitate, Coco-Glucoside, Caprylyl/Capryl Glucoside, Sorbitan Palmitate, Sorbitan Olivate, Butyrospermum Parkii (Shea) Nut Extract, Ethyl Ferulate, Bisabolol, Allantoin, Hydrolyzed Jojoba Esters, Acacia Senegal Gum, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Isostearic Acid, Lecithin, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Decapeptide-52*, Oryza Sativa (rice) Starch,Camellia Sinensis Leaf Extract, Euterpe Oleracea Fruit Extract, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Xanthan Gum, Sodium Phytate, Propylene Glycol, Phenoxyethanol, sodium Benzoate, Potassium Sorbate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OS-01 FACE SPF UNTINTEDOS-01 FACE SPF UNTINTED

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84451-003-01OS-01 Face SPF BS SPF30 Untinted40 g in 1 TUBECREAM401
84451-003-02OS-01 Face SPF BS SPF30 Untinted1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84451-003OS-01 FACE SPF BS SPF30 UNTINTED (ZINC OXIDE) CREAM [ONESKIN INC.]1Current NDC, 2 package rows20240915_2205ec0e-ac3f-299f-e063-6294a90a2174.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
84451-00384451-003-01, 84451-003-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 38 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HELIANTHUS ANNUUS SPROUT4P26HG1S5WIACT
XANTHAN GUMTTV12P4NEEIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ISOSTEARIC ACIDX33R8U0062IACT
CAPRYLYL/CAPRYL OLIGOGLUCOSIDEE00JL9G9K0IACT
ALLANTOIN344S277G0ZIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
STARCH, RICE4DGK8B7I3SIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETYL PALMITATE5ZA2S6B08XIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
PHYTATE SODIUM88496G1ERLIACT
SHEANUT84H6HBP32LIACT
LEVOMENOL24WE03BX2TIACT
HYDROLYZED JOJOBA ESTERS (POTASSIUM SALTS)CH428W5O62IACT
ACACIA5C5403N26OIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
WATER059QF0KO0RIACT
SORBITAN MONOPALMITATE77K6Z421KUIACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SORBITAN OLIVATEMDL271E3GRIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PEPTIDE-T05DYM3ZS1XIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
COCO GLUCOSIDEICS790225BIACT
ETHYL FERULATE5B8915UELWIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
ACAI46AM2VJ0AWIACT
CAESALPINIA SPINOSA FRUIT PODEXY4496LWDIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ZINC OXIDESOI2LOH54ZACTIB

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
OS-01 Face SPF BS SPF30 UntintedZINC OXIDEONESKIN INC.2205ec0e-ac3f-299f-e063-6294a90a21742024-09-13WarningsExact identifier
ndc (package): 84451-003-01
ndc (package): 84451-003-02
ndc (product): 84451-003
ndc11 (package): 84451000302
ndc11 (package): 84451000301
spl id: 22060b23-45e8-c29d-e063-6294a90a4be6
spl set id: 2205ec0e-ac3f-299f-e063-6294a90a2174

Reported adverse events (FAERS/openFDA)#

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