Active Ingredient
HOMOSALATE 15%
OCTOCRYLENE 10%
OCTINOXATE 7.4%
OXYBENZONE 4%
AVOBENZONE 3%
Skintific Outdoor Sun Broad Spectrum Spf 50 Spray
FDA Label NDC 87467-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gold Inti Trade Corporation for the product Skintific Outdoor Sun Broad Spectrum Spf 50 (NDC 87467-001). 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 ingredient, purpose, uses, warnings, • do not use, •stop use and ask a doctor, •when using this product, •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
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.
• Do Not Use
on damaged or broken skin.
•Stop Use And Ask A Doctor
if rash occurs
•When Using This Product
keep out of eyes. Rinse with water to remove
•Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Flammable:
Keep away from fire or flame.
•Avoid Spraying In Eyes.
Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 °F.
Directions
•Apply liberally 15 minutes before sun exposure.
•Shake well before use.
•Do not spray directly into face. Spray on hands then apply to face.
•Apply to all skin exposed to the sun
•Reapply at least every 2 hours.
•Use a water-resistant sunscreen if swimming or sweating.
•Children under 6 months: Ask a doctor.
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.
Other Information
• store at controlled room temperature 20°-25°C (68°-77°F). Protect from freezing and excessive heat over 40°C (104°F).
Inactive Ingredients
BUTANE, PROPANE, ISOBUTANE, ALCOHOL DENAT., ISODODECANE, BUTYL OCTYL SALICYLATE, POLYMETHYLSILSESQUIOXANE, SILICA, BISABOLOL, MENTHYLLACTATE, METHYL DIISOPROPYL PROPIONAMIDE, METHICONE, BHT, CERAMIDE NP.
87467-001-01
87467-001-01 (Skintific 452)
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