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ONE SIZE ON TIL DAWN

ONE SIZE ON TIL DAWN MATTIFYING SUNSCREEN MAKEUP SETTING SPRAY

Approved
Approval ID

3f05d90b-9274-4d21-e063-6294a90a8485

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 17, 2025

Manufacturers
FDA

Pogi Beauty LLC

DUNS: 117433519

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

ONE SIZE ON TIL DAWN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85307-580
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
ONE SIZE ON TIL DAWN
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 17, 2025
FDA Product Classification

INGREDIENTS (17)

FRAGRANCE CLEAN ORC0600327Inactive
Code: 329LCV5BTF
Classification: IACT
LIMONENE, (+/-)-Inactive
Code: 9MC3I34447
Classification: IACT
LINALOOL, (+/-)-Inactive
Code: D81QY6I88E
Classification: IACT
HEXYL CINNAMALInactive
Code: 7X6O37OK2I
Classification: IACT
DIMETHYL ETHERInactive
Code: AM13FS69BX
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIISOPROPYL ADIPATEInactive
Code: P7E6YFV72X
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TETRAHEXYLDECYL ASCORBATEInactive
Code: 9LBV3F07AZ
Classification: IACT
CAMELLIA SINENSIS LEAFInactive
Code: W2ZU1RY8B0
Classification: IACT
ISODODECANEInactive
Code: A8289P68Y2
Classification: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
HAMAMELIS VIRGINIANA LEAFInactive
Code: T07U1161SV
Classification: IACT
HOMOSALATEActive
Quantity: 13 g in 100 g
Code: V06SV4M95S
Classification: ACTIB
OCTISALATEActive
Quantity: 4.5 g in 100 g
Code: 4X49Y0596W
Classification: ACTIB
AVOBENZONEActive
Quantity: 3 g in 100 g
Code: G63QQF2NOX
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/1/2025

Principal display Panel

ONE/SIZE

SPF 28

ON 'TIL DAWN

MATTIFYING

SUNSCREEN

MAKEUP

SETTING SPRAY

BROAD SPECTRUM

SPF 28

Net wt. 3.6 oz (102 g)

Net wt. 1.05 oz (30 g)

![ONE/SIZE ON TIL DAWN Retail Label](/dailymed/image.cfm?name=OS-OnTilDawn- SPF28MattifyingSunscreenSettingSpray-102g-RetailLabel.jpg&id=898449)![ONE/SIZE ON TIL DAWN Travel Label](/dailymed/image.cfm?name=OS-OnTilDawn- SPF28MattifyingSettingSpray-30g-Travel-Label.jpg&id=898449)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/1/2025

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (seeDirections), decreases the risk of skin cancer and early skin aging caused by the sun.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/1/2025

Active Ingredients

Avobenzone 3%

Homosalate 13%

Octisalate 4.5%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/1/2025

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 6/1/2025

Warnings

For external use only

Extremely flammable

  • do not use in the presence of a flame or spark or while smoking.

Do not use

  • on damaged or broken skin

When using this product

  • avoid apraying in eyes. Rinse with water to remove.
  • Do not punctue or incinerate. Contents under pressure.
  • Do not store at temperature above 104 F (40 C).
  • Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Stop use and ask a doctor if

  • rash occurs.

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/1/2025

Directions

  • shake well before use

  • keep eyes closed during application

  • hold container 10 to 12 inches away from face, and spray in a circular motion for even distribution on skin

  • apply liberally 15 minutes before sun exposure

  • do not apply in windy conditions

  • use in a well-ventilated area and avoid inhalation

  • reapply at least every 2 hours

  • use a water-resistant sunscreen if swimming or sweating *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.
    • children under 6 months of age: Ask a doctor

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 6/1/2025

Other information

  • protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/1/2025

Inactive ingredients

Dimethyl Ether, SD Alcohol 40-B, Isododecane, Methacryloyl Ethyl Betaine/Acrylates Copolymer, Silica, Diisopropyl Adipate, Fragrance (Parfum), Glycerin, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Tea ( Camellia sinensis) Leaf Extract, Witch Hazel ( Hamamelis virginiana) Leaf Extract, Limonene, Linalool, Hexyl Cinnamal

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/1/2025

Questions?

+1-855-777-0440

You may also report serious side effects to this phone number. Monday - Friday (8 a.m to 5 p.m. PST)

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