Prescriptives
FDA Label NDC 59158-913

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Prescriptives Inc. for the product Prescriptives (NDC 59158-913). 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 other, active ingredients, purpose, use, otc - do not use, otc - when using, otc - stop use, 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

Other

Drug Facts

DIST. NEW YORK, N.Y. 10022

Active Ingredients

Octinoxate 4.10%
Titanium Dioxide 1.40%
Zinc Oxide 1.50%

Purpose

Sunscreen

Use

helps prevent sunburn

Otc - Do Not Use

For external use only

Do not use on damaged or broken skin

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

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

Directions

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply at least every two 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

Inactive Ingredients

water\aqua\eau • cyclopentasiloxane • dimethicone • phenyl trimethicone • dimethicone silylate • butylene glycol • peg/ppg-18/18 dimethicone • silica • yeast extract\faex\extrait de levure • ethylhexylglycerin • octyldodecyl neopentanoate • tocopheryl acetate • triethoxycaprylylsilane • glycerin • polysilicone-11 • magnesium sulfate • disteardimonium hectorite • dipeptide-2 • palmitoyl tetrapeptide-7 • sorbitan sesquioleate • acetyl hexapeptide-8 • polyglyceryl-6 polyricinoleate • laureth-7 • isopropyl titanium triisostearate • propylene carbonate • chamomilla recutita (matricaria) • hesperidin methyl chalcone • steareth-20 • alumina • chloroxylenol • phenoxyethanol • [+/- titanium dioxide (ci 77891) • mica • iron oxides (ci 77491, ci 77492, ci 77499)] <iln32488>

Other Information

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

Principal Display Panel - 3.5 Ml Carton

PRESCRIPTIVES
Site Unseen
Brightening Concealer Broad Spectrum SPF 15
0.12 FL. OZ./OZ. LIQ./3.5 ml

Principal Display Panel (3.5 ml Carton)

Principal Display Panel (3.5 ml Carton)

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