Zinc Oxide: Package Insert and Label Information

ZINC OXIDE- zinc oxide lotion
Goodier Cosmetics LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DAILY FACE
CREAM


SUNSCREEN
ZINC OXIDE
BROAD SPECTRUM SPF 20

PATENTED
NERIUM ALOE
EXTRACT
NAE-8®

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
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.

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
• Storage: Transport and store in a cool, dry
area. Keep away from direct sunlight.
• 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 (NAE-8®), Hydrolyzed Egg Shell Membrane (Peptide Matrix — Collagen & Elastin),
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

Questions?
1-(866)-535-5888 M-F (9 am to 5 pm CST)

Manufactured for:
Nerium SkinCare, Inc.San Antonio, TX 78230

Pure Daily Face Cream SPF20
(click image for full-size original)

1floz Pure Daily Face Cream

Advanced Daily Face Cream SPF20
(click image for full-size original)

1floz Advanced Daily Face Cream

ZINC OXIDE daily face cream broad spectrum spf 20 lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10477-1384
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC CATION) ZINC CATION 12.5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
ALKYL (C12-15) BENZOATE
GLYCERIN
ALOE VERA LEAF POLYSACCHARIDES
CETOSTEARYL ALCOHOL
CETETH-20 PHOSPHATE
OLETH-3 PHOSPHATE
ISOSTEARIC ACID
SILICON DIOXIDE
NERIUM OLEANDER LEAF
EGG SHELL MEMBRANE
CAPRYLYL GLYCOL
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE
SUPEROXIDE DISMUTASE (MN) SACCHAROMYCES CEREVISIAE
POLYGONUM AVICULARE WHOLE
DIMETHICONE
CETEARYL GLUCOSIDE
NIACINAMIDE
HYALURONATE SODIUM
TETRAHEXYLDECYL ASCORBATE
GLYCERYL CAPRYLATE
OAT
MATRICARIA CHAMOMILLA
ROSEMARY
.ALPHA.-TOCOPHEROL ACETATE, DL-
GLYCYRRHIZINATE DIPOTASSIUM
PALMITOYLLYSYLVALYLDIAMINOBUTYROYLTHREONINE
PALMITOYL TRIPEPTIDE-5
TETRADECYL AMINOBUTYROYLVALYLAMINOBUTYRIC UREA TRIFLUOROACETATE
GLYCERYL STEARATE CITRATE
MAGNESIUM CHLORIDE
XANTHAN GUM
DISODIUM ETHYLENEDIAMINEDIACETATE
PHENYLPROPANOL
DIHEXADECYL PHOSPHATE
POLYHYDROXYSTEARIC ACID (2300 MW)
POTASSIUM SORBATE
MICA
TITANIUM DIOXIDE
PENTYLENE GLYCOL
PHENOXYETHANOL
SODIUM BENZOATE
TROMETHAMINE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10477-1384-1 1 BOTTLE, PUMP in 1 CARTON contains a BOTTLE, PUMP
1 30 g in 1 BOTTLE, PUMP This package is contained within the CARTON (10477-1384-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 10/01/2019
Labeler — Goodier Cosmetics LLC (007317209)
Establishment
Name Address ID/FEI Operations
Goodier Cosmetics LLC 007317209 manufacture (10477-1384)

Revised: 12/2019 Goodier Cosmetics LLC

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