DAILY SPF 20 OLEANDER FACE CREAM- zinc oxide cream

Daily SPF 20 Oleander Face Cream by

Drug Labeling and Warnings

Daily SPF 20 Oleander Face Cream by is a Otc medication manufactured, distributed, or labeled by Goodier Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NeriumRX™ Daily Age-Defying Face Moisturizer

NERIUM
SKINCARE™

NeriumRX™
Daily Age-Defying
Face Moisturizer

Sunscreen - Zinc Oxide
Broad Spectrum SPF20
Medium Protection

NAE-14™ Proprietary
Nerium Extract

30 ml/1 FL.OZ.

Active Ingredient                          Purpose
Zinc Oxide 12.5%............................Sunscreen

Uses
Helps prevent sunburn
Higher SPF gives more sunburn protection
Provides moderate protection against 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.

Warnings

Do not use on damaged or broken skin

For External Use only
When using this product keep out of eyes.
Rinse with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts

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

Directions
Apply generously before sun exposure and as needed
Children under 6 months of age: 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 10 a.m.- 2 p.m.
wear long-sleeved shirts, pants, hats and sunglasses.

Other Information
Moderate sun protection product
Sun alert: limiting sun exposure, wearing protective clothing, and using sunscreens may
reduce the risks of skin aging, skin cancer, and other harmful effects of the sun
Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients
Water, C12-15 Alkyl Benzoate, Glycerin, Aloe Barbadenis Leaf Juice, Cetearyl Alcohol,
Ceteth-20 Phosphate, Oleth-3 Phosphate, Isostearic Acid, Silica, Nerium Oleander Leaf
Extract, Hydrolyzed Egg Shell Membrane, Caprylyl Glycol, Leuconostoc/Radish Root
Ferment Filtrate, Superoxide Dismutase, Polygonum Aviculare Extract, Dimethicone,
Cetearyl Glucoside, Niacinamide, Sodium Hyaluronate, Tetrahexyldecyl Ascorbate, Glyceryl
Caprylate, Avena Sativa (Oat) Kernel Extract, Chamomilla Recutita (Matricaria) Flower Extract,
Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopheryl Acetate, Dipotassium Glycyrrhizinate,
Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Palmitoyl Tripeptide-5,
Tetradecyl Aminobutyroylvalylaminobutyric Urea Trifluoroacetate, Glyceryl Stearate Citrate,
Magnesium Chloride, Xanthan Gum, Disodium EDTA, Phenylpropanol, Dicetyl Phosphate,
Polyhydroxystearic Acid, Potassium Sorbate, Fragrance, Mica, Titanium Dioxide, Pentylene
Glycol, Phenoxyethanol, Sodium Benzoate, Tromethamine.

Manufactured for:
Nerium SkinCare, Inc.
11467 Huebner Road, Ste 175
San Antonio, TX 78230

Nerium Advanced Daily Face Cream

NERIUM
SKINCARE, INC.

ADVANCED

SUNSCREEN
ZINC OXIDE
BROAD SPECTRUM SPF 20

DAILY FACE CREAM

PATENTED
NERIUM OLEANDER EXTRACT

30 mL/1 fl.oz.

Active Ingredient                          Purpose
Zinc Oxide 12.5%............................Sunscreen

Uses
Helps prevent sunburn
Higher SPF gives more sunburn protection
Provides moderate protection against 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.

Warnings

Do not use on damaged or broken skin

For External Use only
When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts

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

Directions
Apply generously before sun exposure and as needed
Children under 6 months of age: 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 10 a.m.- 2 p.m.
wear long-sleeved shirts, pants, hats and sunglasses.

Other Information
Moderate sun protection product
Sun alert: limiting sun exposure, wearing protective clothing, and using sunscreens may
reduce the risks of skin aging, skin cancer, and other harmful effects of the sun
Protect the product in this container from
excessive heat and direct sun.

Inactive Ingredients
Water, C12-15 Alkyl Benzoate, Glycerin, Aloe Barbadenis Leaf Juice, Cetearyl Alcohol,
Ceteth-20 Phosphate, Oleth-3 Phosphate, Isostearic Acid, Silica, Nerium Oleander Leaf
Extract, Hydrolyzed Egg Shell Membrane, Caprylyl Glycol, Leuconostoc/Radish Root
Ferment Filtrate, Superoxide Dismutase, Polygonum Aviculare Extract, Dimethicone,
Cetearyl Glucoside, Niacinamide, Sodium Hyaluronate, Tetrahexyldecyl Ascorbate, Glyceryl
Caprylate, Avena Sativa (Oat) Kernel Extract, Chamomilla Recutita (Matricaria) Flower Extract,
Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopheryl Acetate, Dipotassium Glycyrrhizinate,
Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Palmitoyl Tripeptide-5,
Tetradecyl Aminobutyroylvalylaminobutyric Urea Trifluoroacetate, Glyceryl Stearate Citrate,
Magnesium Chloride, Xanthan Gum, Disodium EDTA, Phenylpropanol, Dicetyl Phosphate,
Polyhydroxystearic Acid, Potassium Sorbate, Fragrance, Mica, Titanium Dioxide, Pentylene
Glycol, Phenoxyethanol, Sodium Benzoate, Tromethamine.

Manufactured for:
Nerium SkinCare, Inc.
11467 Huebner Road, Ste 175
San Antonio, TX 78230

PRINCIPAL DISPLAY PANEL

Nerium RX Label 30mL

Nerium Advanced Label 30mL

INGREDIENTS AND APPEARANCE

DAILY SPF 20 OLEANDER FACE CREAM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10477-0063
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	12.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
ISOSTEARIC ACID (UNII: X33R8U0062)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10477-0063-1	1 in 1 CARTON	11/17/2017
1		30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/17/2017

Labeler - Goodier Cosmetics (007317209)

Registrant - Goodier Cosmetics (007317209)

Establishment
Name	Address	ID/FEI	Business Operations
Goodier Cosmetics		007317209	manufacture(10477-0063)