Nu-derm Healthy Skin Protection Cream
FDA Label NDC 62032-200

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Obagi Cosmeceuticals Llc for the product Nu-derm Healthy Skin Protection (NDC 62032-200). 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, do not use, stop use and ask a doctor, when using this product, 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

Octinoxate, 7.5%, Zinc oxide, 9%

Purpose

Sunscreen

Uses

  • helps prevent sunburn.

Warnings

  • For external use only.

Do Not Use

  • On damaged or broken skin

Stop Use And Ask A Doctor

  • If rash occurs

When Using This Product

  • Keep out of eyes. Rinse with water to remove.

Keep Out Of Reach Of Children.

  • If swallowed, get medical help or contact a Poison Control Center right away.

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 sun 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

Inactive Ingredients

butylparaben, cetearyl alcohol, citric acid, C13-14 isoparaffin, DEA-cetyl phosphate, disodium EDTA, ethylhexyl stearate, ethylparaben, isobutylparaben, isopropyl palmitate, laureth-7, methylparaben, phenoxyethanol, polyacrylamide, polyether-1, polysorbate 60, propylparaben, sodium hydroxide, triethoxycaprylylsilane, water

Other Information

  • store at controlled room temperature: 15°C–25°C (59°F–77°F)
  • protect this product from excessive heat and direct sun

Questions Or Comments?

1.800.636.7546 Monday–Friday 9 a.m.–4 p.m. Pacific Time

Distributed by OMP, Inc., Long Beach, CA 90806

©2012 Obagi Medical Products, Inc. All rights reserved.

  •  www.obagi.com Made in USA 10705810Z 7058

Principal Display Panel – 85 G Bottle Label

The Skin Cancer Foundation

recommends this Product as an

effective UVA/UVB sunscreen

OBAGI
NU-DERM®

AM

HEALTHY SKIN
PROTECTION
BROAD SPECTRUM SPF 35

6

SUNSCREEN LOTION

Net wt. 3 oz (85 g)

C:\users\divya.raavi\desktop\nu-derm Healthy Skin Protection\new Updated One\nu-derm.jpg (Nu Derm 01)

C:\users\divya.raavi\desktop\nu-derm Healthy Skin Protection\new Updated One\nu-derm.jpg (Nu Derm 01)

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