One Size On Til Dawn Aerosol, Spray
FDA Label NDC 85307-580

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pogi Beauty Llc for the product One Size On Til Dawn (NDC 85307-580). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - ask doctor, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purpose

→ Uses

→ Warnings

→ Otc - Do Not Use

→ Otc - When Using

→ Otc - Ask Doctor

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel

Active Ingredients

Avobenzone 3%

Homosalate 13%

Octisalate 4.5%

Purpose

Sunscreen

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

For external use only

Extremely flammable

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

Otc - Do Not Use

Do not use

on damaged or broken skin

Otc - When Using

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.

Otc - Ask Doctor

Stop use and ask a doctor if

rash occurs.

Otc - Keep Out Of Reach Of Children

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

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 Information

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

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