Nu-derm®

Nu-derm®
SPL v1
SPL
SPL Set ID 04ca07d8-46dc-469c-8482-ffcb3d5bc943
Route
TOPICAL
Published
Effective Date 2012-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (75 mg) Zinc Oxide (105 mg)
Inactive Ingredients
Cyclomethicone 5 Water Peg-10 Dimethicone (600 Cst) Pentylene Glycol Stearyl Alcohol Polyoxyl 20 Cetostearyl Ether Phenyl Trimethicone Peg-40 Stearate Sodium Dihydroxycetyl Phosphate Hydrogenated Palm Glycerides Citric Acid Monohydrate Cetostearyl Alcohol .alpha.-tocopherol Acetate 1,2-hexanediol Caprylyl Glycol Tropolone Chlorphenesin Xanthan Gum Potassium Sorbate Sodium Benzoate Tetrahexyldecyl Ascorbate Ubidecarenone Edetate Disodium Methylisothiazolinone Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Squalane Polysorbate 60

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-11-07

Description

Octinoxate 7.5%, Zinc Oxide 10.5%


Medication Information

Description

Octinoxate 7.5%, Zinc Oxide 10.5%

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

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

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.

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. Children under 6 months: Ask a doctor.

Other Information

Store at controlled room temperature: 15°C–25°C (59°F–77°F). Protect this product from excessive heat and direct sun.

Active Ingredients

Octinoxate 7.5%, Zinc Oxide 10.5%

Inactive Ingredients

1,2-hexanediol, caprylyl glycol, ceteareth-20, cetearyl alcohol, chlorphenesin, citric acid, cyclopentasiloxane, dimethicone crosspolymer-3, disodium EDTA, hydrogenated palm glycerides, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylisothiazolinone, PEG-10 dimethicone, PEG-40 stearate, pentylene glycol, phenyl trimethicone, polysilicone-11, polysorbate 60, potassium sorbate, sodium benzoate, sodium dihydroxycetyl phosphate, squalane, stearyl alcohol, tetrahexyldecyl ascorbate, tocopheryl acetate, tropolone, ubiquinone, water, xanthan gum

Questions Or Comments?

1.800.636.7546

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

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.

Principal Display Panel 85 G Tube Label

OBAGI

NU-DERM
®

Sun Shield

MATTE

Broad

Spectrum

SPF 50

Sunscreen

Lotion

PA+++

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)

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

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.

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. Children under 6 months: Ask a doctor.

Other Information (Other information)

Store at controlled room temperature: 15°C–25°C (59°F–77°F). Protect this product from excessive heat and direct sun.

Active Ingredients (Active ingredients)

Octinoxate 7.5%, Zinc Oxide 10.5%

Inactive Ingredients (Inactive ingredients)

1,2-hexanediol, caprylyl glycol, ceteareth-20, cetearyl alcohol, chlorphenesin, citric acid, cyclopentasiloxane, dimethicone crosspolymer-3, disodium EDTA, hydrogenated palm glycerides, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, methylisothiazolinone, PEG-10 dimethicone, PEG-40 stearate, pentylene glycol, phenyl trimethicone, polysilicone-11, polysorbate 60, potassium sorbate, sodium benzoate, sodium dihydroxycetyl phosphate, squalane, stearyl alcohol, tetrahexyldecyl ascorbate, tocopheryl acetate, tropolone, ubiquinone, water, xanthan gum

Questions Or Comments? (Questions or comments?)

1.800.636.7546

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

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.

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

OBAGI

NU-DERM
®

Sun Shield

MATTE

Broad

Spectrum

SPF 50

Sunscreen

Lotion

PA+++

Net wt. 3 oz. (85 g.)


Advanced Ingredient Data


Raw Label Data

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