Day Care For Hands Broad Spectrum Spf 15
FDA Label NDC 68828-400

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Jafra Cosmetics International for the product Day Care For Hands Broad Spectrum Spf 15 (NDC 68828-400). 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.

Otc - Active Ingredient

Active Ingredients                       Purpose

Avobenzone 3% ......................... Sunscreen

Octinoxate 7.5% ......................... Sunscreen

Octisalate 4% ............................. Sunscreen

Oxybenzone 2% ......................... Sunscreen

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 product is 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 minths: 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 10a.m. - 2p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses

Inactive Ingredient

Water/Aqua, Polyglycery-3 Methylglucose Distearate, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Glyceryl Stearate, Glycerin, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Ipomoea Digitata (Fingerleaf Morning Glory) Extract, Withania Somniferia (Winter Cherry) Extract, Vigna Radiata (Mung Bean) Extract, Trisodium EDTA, Panthenol, Tocopheryl Acetate, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Biasacchardie Gum-4, Chondrus Crispus (Carrageenan) Extract, Chamomilla Recutita (Matricaria) Extact, Morus Alba Extract, Lonicera Caprifolium (Honeysuckle) Flower Extract, Potassium Sorbate, Fragrance/Parfum

Package Label.Principal Display Panel

JAFRA

spa

Day Care for Hands

Broad Spectrum SPF 15

with intellishield

75ml e 2.5 FL OZ (US)

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