Ageless Solar Defense (spf 30)
FDA Label NDC 82084-0011

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Divine 369 Llc for the product Ageless Solar Defense (spf 30) (NDC 82084-0011). 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 drug facts, active ingredients, purpose, uses, warnings, do not use, stop use and contact your doctor if, 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

Drug Facts

Active Ingredients

Octinoxate 7.5%
Octisalate 5.0%
Oxybenzone 4.0%
Avobenzone 3.0%

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 Contact Your Doctor If

  • rash occurs.

Keep Out Of Reach Of Children.

  • If swallowed, get medical help, or contact a poison control center right away.

  • Do not apply too closely to the eye area. Rinse with water to remove.

Directions

  • Apply liberally to face and body at least 15 minutes before sun exposure or two minutes before applying makeup.
  • Reapply:
  • After 80 minutes of swimming or sweating
  • Immediately after towel drying.
  • At least every 2 hours.
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and 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 specially, 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

Water (Aqua), Isopropyl Palmitate, Isoeicosane, Potassium Cetyl Phosphate, Glycerin, Ethylhexyl Methoxycrylene, Silica, Cetyl Dimethicone, Hydroxyethylacrylate/sodium acryloyldimethyl taurate copolymer, Dimethicone, Polyglyceryl-3 Diisostearate, Cetearyl Alcohol, Polysorbate 60, Isohexadecane, Hydroxyethylcellulose, Phenoxyethanol, Glyceryl Stearate, PEG-100 Stearate, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Butylene Glycol, Punica Granatum (Pomegranate) Extarct, Camellia Oleifera Leaf Extract

Questions Or Comments?

Contact us at: [email protected]

Monday - Friday (9am - 5pm PST)

Dist-by Divine 369 LLC. San Francisco CA, 94124

www.audiaskincare.com

Package Labeling:

Label0 (Label0)

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