Nu-derm

Nu-derm
SPL v7
SPL
SPL Set ID cfb6a918-1403-4cf2-86d8-d66dd764bb6c
Route
TOPICAL
Published
Effective Date 2019-09-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (75 mg) Zinc Oxide (90 mg)
Inactive Ingredients
Isopropyl Palmitate Water Ethylhexyl Stearate Cetostearyl Alcohol Polysorbate 60 C13-14 Isoparaffin Methylparaben Laureth-7 Propylparaben Edetate Disodium Butylparaben Diethanolamine Cetyl Phosphate Phenoxyethanol Ethylparaben Isobutylparaben Sodium Hydroxide Triethoxycaprylylsilane Citric Acid Monohydrate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2002-01-01 Until 2020-03-31

Description

Drug Facts


Medication Information

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if rash occurs

Section 50567-7

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

Section 50570-1

Do not use on damaged or broken skin

Section 55105-1
Active ingredients Purpose
Octinoxate 7.5% Sunscreen
Zinc Oxide 9% Sunscreen
Warnings

For external use only

Directions
  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • 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
Other Information
  • store at controlled room temperature: 15°-25°C (59°-77°F)
  • protect this product from excessive heat and direct sun
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 (aqua)

Questions Or Comments?

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

Principal Display Panel 85 G Bottle Label

RECOMMENDED

SKIN

CANCER

FOUNDATION

DAILY USE

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)


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 55105-1 (55105-1)
Active ingredients Purpose
Octinoxate 7.5% Sunscreen
Zinc Oxide 9% Sunscreen
Warnings

For external use only

Directions
  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • 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
Other Information (Other information)
  • store at controlled room temperature: 15°-25°C (59°-77°F)
  • protect this product from excessive heat and direct sun
Inactive Ingredients (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 (aqua)

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel 85 G Bottle Label (PRINCIPAL DISPLAY PANEL - 85 g Bottle Label)

RECOMMENDED

SKIN

CANCER

FOUNDATION

DAILY USE

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)


Advanced Ingredient Data


Raw Label Data

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