FDA.reportPublic FDA data

OS-01 Body SPF 30

Manufacturer
ONESKIN, INC
Effective date
2024-08-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:18:47

Label at a glance#

ProductOS-01 Body SPF 30
Active ingredientZINC OXIDE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients – Zinc Oxide 14 %

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 after 80 minutes of swimming or sweating.
immediately after towel drying, at least every 2 hours
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

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Caprylic/Capric Triglyceride 40 - 65 Butyloctyl Salicylate, C13-15 Alkane, Stearalkonium Hectorite,Coconut Alkanes, Euphorbia Cerifera (Candelilla) Wax, Helianthus Annuus (Sunflower) Seed Wax, Propylene Carbonate, Quaternium-90 Bentonite, Butyrospermum Parkii Nut Extract, Decapeptide-52, Camellia Oleifera (Tea) Seed Oil, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Aloe Barbadensis Leaf Extract, Carthamus Tinctorius Seed Oil, Lactobacillus/Acerola Cherry Ferment, Coco-Caprylate/Caprate, Ceramide NP, Ceramide AP, Ceramide EOP, Ethylhexylglycerin, Caprylyl Glycol, Hexylene Glycol, Polyhydroxystearic acid, Polyglyceryl-3 Polyricinoleate, Isostearic acid, Lecithin, Phytosphingosine, Cholesterol, Sodium lauroyl lactylate , Carbomer, Xanthan gum, Water, Propylene Glycol ,Triethyl Citrate, Citric Acid, Sodium Benzoate, Phenoxyethanol.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Body SPF 30Body SPF 30

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
84451-001-01OS-01 Body SPF 30100 g in 1 TUBECREAM1001
84451-001-02OS-01 Body SPF 301 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84451-001OS-01 BODY SPF 30 (ZINC OXIDE) CREAM [ONESKIN, INC]1Current NDC, 2 package rows20240906_20eb4d43-cf4d-dde3-e063-6394a90a6cb8.zip

Products#

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

DailyMed product names page 1 of 1 · 40 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84451-00184451-001-01, 84451-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 39 matching rows.

Name, UNII, Kind table
NameUNIIKind
BIFIDOBACTERIUM ANIMALIS LACTIS5307V7XW8IIACT
CANDELILLA WAXWL0328HX19IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
SHEANUT84H6HBP32LIACT
PHYTOSPHINGOSINEGIN46U9Q2QIACT
SODIUM BENZOATEOJ245FE5EUIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAESALPINIA SPINOSA FRUIT PODEXY4496LWDIACT
SAFFLOWER OIL65UEH262ISIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
SODIUM LAUROYL LACTYLATE7243K85WFOIACT
HELIANTHUS ANNUUS SPROUT4P26HG1S5WIACT
ISOSTEARIC ACIDX33R8U0062IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
STEARALKONIUM HECTORITEOLX698AH5PIACT
QUATERNIUM-90 BENTONITE97K5YEF88CIACT
CAMELLIA OILT1PE06G0VEIACT
ALOE VERA LEAFZY81Z83H0XIACT
MALPIGHIA EMARGINATA SEED1X7L93686MIACT
CERAMIDE NP4370DF050BIACT
CERAMIDE APF1X8L2B00JIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CHOLESTEROL97C5T2UQ7JIACT
XANTHAN GUMTTV12P4NEEIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
C13-15 ALKANE114P5I43UJIACT
COCONUT ALKANES1E5KJY107TIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLENE CARBONATE8D08K3S51EIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CAPRYLYL GLYCOL00YIU5438UIACT
WATER059QF0KO0RIACT
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 Body SPF 30ZINC OXIDEONESKIN, INC20eb4d43-cf4d-dde3-e063-6394a90a6cb82024-08-30WarningsExact identifier
ndc (package): 84451-001-01
ndc (package): 84451-001-02
ndc (product): 84451-001
ndc11 (package): 84451000102
ndc11 (package): 84451000101
spl id: 20eb5e03-fcd2-d66b-e063-6394a90a4089
spl set id: 20eb4d43-cf4d-dde3-e063-6394a90a6cb8

Reported adverse events (FAERS/openFDA)#

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