OTC - ACTIVE INGREDIENT SECTION
Active ingredients : Zinc Oxide 17.5%.
OS-01 FACE SPF BS SPF 30 TINTED DEEP
- Manufacturer
- ONESKIN INC.
- Effective date
- 2025-05-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:01:14
Label at a glance#
ProductOS-01 FACE SPF BS SPF 30 TINTED DEEP
Active ingredientZINC OXIDE
Label structure12 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Purpose : Sunscreen
INDICATIONS & USAGE SECTION
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.
WARNINGS SECTION
Warnings
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 eyes.
Rinse with water to remove.
OTC - STOP USE SECTION
Stop use and ask a 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
Directions:
Apply liberally 15 minutes before sun exposure.
Reapply at least every 2 hours
Use a water-resistant sunscreen If swimming or sweating.
Children under 6 months of age: Ask a Doctor.
Sun Probation 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 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, Triethoxycaprylylsilane, Alumina, Magnesium Oxide, Iron Oxides (CI 77491, CI 77492, CI 77499)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84451-005-01 | OS-01 FACE SPF BS SPF 30 TINTED DEEP | 40 g in 1 TUBE | CREAM | 40 | 1 | |
| 84451-005-02 | OS-01 FACE SPF BS SPF 30 TINTED DEEP | 1 in 1 CARTON | CREAM | 1 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- OS-01 FACE SPF BS SPF 30 TINTED DEEP
- Zinc Oxide
- SORBITAN PALMITATE
- SODIUM PHYTATE
- BISABOLOL
- CETYL PALMITATE
- COCO GLUCOSIDE
- CAMELLIA SINENSIS LEAF
- XANTHAN GUM
- CETEARYL ALCOHOL
- METHYL DIHYDROABIETATE
- CAPRYLYL/CAPRYL GLUCOSIDE
- ACACIA SENEGAL GUM
- POLYGLYCERYL-3 PENTARICINOLEATE
- CI 77499
- WATER
- CAPRYLYL GLYCOL
- MAGNESIUM OXIDE
- CI 77491
- .ALPHA.-TOCOPHEROL ACETATE
- HELIANTHUS ANNUUS SPROUT
- TRIETHOXYCAPRYLYLSILANE
- HEXYLENE GLYCOL
- ETHYL FERULATE
- LECITHIN, SUNFLOWER
- ORYZA SATIVA (RICE) STARCH
- PHENOXYETHANOL
- CI 77492
- SORBITAN OLIVATE
- SHEANUT
- CAESALPINIA SPINOSA FRUIT POD
- ETHYLHEXYLGLYCERIN
- CAPRYLIC/CAPRIC TRIGLYCERIDE
- GLYCERIN
- ALLANTOIN
- HYDROLYZED JOJOBA ESTERS
- POLYHYDROXYSTEARIC ACID (2300 MW)
- ISOSTEARIC ACID
- PROPYLENE GLYCOL
- SODIUM BENZOATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 84451-005 | 84451-005-01, 84451-005-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| OS-01 FACE SPF BS SPF 30 TINTED DEEP | ZINC OXIDE | ONESKIN INC. | 3581f578-e19e-9ace-e063-6294a90acc34 | 2025-05-19 | Warnings | 84451-005-01 84451-005-02 84451-005 84451000501 84451000502 3581efdc-41fa-a450-e063-6294a90a4e56 3581f578-e19e-9ace-e063-6294a90acc34 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.