Intral Sensitive Skin Environmental Lightweight Shield Broad Spectrum Spf50 Lotion
FDA Label NDC 16555-008

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Darphin Dist. for the product Intral Sensitive Skin Environmental Lightweight Shield Broad Spectrum Spf50 (NDC 16555-008). 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, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredients

Titanium dioxide 6.3%
Zinc oxide 4.0%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

For external use only

Otc - Do Not Use

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: ask a doctor

Inactive Ingredients

water\aqua\eau, dimethicone, butyloctyl salicylate, polydiethylsiloxane, c12-15 alkyl benzoate, isononyl isononanoate, diethylhexyl succinate, neopentyl glycol diheptanoate, methyl trimethicone, butylene glycol, ethylhexyl methoxycrylene, lauryl peg-9 polydimethylsiloxyethyl dimethicone, silica, laureth-4, cetyl peg/ppg-10/1 dimethicone, dipentaerythrityl tri-polyhydroxystearate, dimethicone silylate, hydrolyzed wheat protein/pvp crosspolymer, isostearic acid, caprylyl glycol, dimethicone crosspolymer-3, polyhydroxystearic acid, triethoxycaprylylsilane, dimethicone/peg-10/15 crosspolymer, dipropylene glycol, phenoxyethanol, iron oxides (ci 77491), iron oxides (ci 77492) <iln41905>

Other Information

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

Principal Display Panel - 30 Ml Bottle Carton

DARPHIN
PARIS

INTRAL

SENSITIVE SKIN

ENVIRONMENTAL
LIGHTWEIGHT SHIELD

BROAD SPECTRUM
SPF 50

30 ml e/1 FL.OZ.LIQ.

Principal Display Panel (30 ml Bottle Carton)

Principal Display Panel (30 ml Bottle Carton)

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