Otc - Active Ingredient
Active Ingredients Purpose
Avobenzone 3% Sunscreen
Homosalate 15% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 7% Sunscreen
Octinoxate 7.5 % Sunscreen
Sun-defying Sunscreen Oil Broad Spectrum Spf 50
FDA Label NDC 75936-125
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Taylor James, Ltd. for the product Sun-defying Sunscreen Oil Broad Spectrum Spf 50 (NDC 75936-125). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
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
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.
Indications & Usage
Stop use and ask a doctor if rash occurs
Warnings
Warnings
· For external use only
· Do not use on damaged or broken skin
· When using this product keep out of eyes. Rinse with water to remove.
Dosage & Administration
Directions
· Apply liberally 15 minutes before sun exposure
· Use a water resistant sunscreen if swimming or sweating
· Reapply at least every 2 hours
· 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 broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
Inactive Ingredient
Octyl Dodecanol, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, SD Alcohol 40-B, Ethylenediamine/Hydrogenated Dimer Dilinoleate Copolymer Bis-Di-C14-18 Alkyl Amide, Isodecyl Neopentanoate, Diisopropyl Sebacate, Lauryl Lactate, Alaria Esculenta Extract, Limnanthes Alba (Meadowfoam) Seed Oil, Raphanus Sativus (Radish) Seed Oil, Vitis Vinifera (Grape) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Tocotrienol, Argania Spinosa Kernel Oil, Cocos Nucifera (Coconut) Oil, Butyrospermum Parkii (Shea) Butter, Punica Granatum Fruit Extract, Citrus Grandis (Grapefruit) Peel Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Tangerina (Tangerine) Peel Extract, Citrus Limon (Lemon) Peel Extract, Calendula Officinalis Flower Extract
Package Label.Principal Display Panel
Secondary (Sundefyingoil)
Supergoop!
Sun-Defying Sunscreen oil with Meadowfoam
Broad Spectrum SPF 50
5 Fl. Oz. / 148 ml
* Please review the disclaimer below.
