ZINC OXIDE- daily face cream broad spectrum spf 20 lotion

Zinc Oxide by

Drug Labeling and Warnings

Zinc Oxide by is a Otc medication manufactured, distributed, or labeled by Goodier Cosmetics LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DAILY FACE
CREAM

SUNSCREEN
ZINC OXIDE
BROAD SPECTRUM SPF 20

PATENTED
NERIUM ALOE
EXTRACT
NAE-8®

ACTIVE INGREDIENT

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

INDICATIONS & USAGE

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

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.

INSTRUCTIONS FOR USE

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 SAFETY INFORMATION

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 INGREDIENT

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

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

1floz Pure Daily Face Cream

1floz Advanced Daily Face Cream

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	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 POLYSACCHARIDES (UNII: W21O437517)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
ISOSTEARIC ACID (UNII: X33R8U0062)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NERIUM OLEANDER LEAF (UNII: 7KV510R6H6)
EGG SHELL MEMBRANE (UNII: N7QBR4212V)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
SUPEROXIDE DISMUTASE (MN) SACCHAROMYCES CEREVISIAE (UNII: 0192074X0K)
POLYGONUM AVICULARE WHOLE (UNII: M990N03611)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
NIACINAMIDE (UNII: 25X51I8RD4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
OAT (UNII: Z6J799EAJK)
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)
ROSEMARY (UNII: IJ67X351P9)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PALMITOYLLYSYLVALYLDIAMINOBUTYROYLTHREONINE (UNII: 1615WE9073)
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)
TETRADECYL AMINOBUTYROYLVALYLAMINOBUTYRIC UREA TRIFLUOROACETATE (UNII: 0UBP26S1LG)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
XANTHAN GUM (UNII: TTV12P4NEE)
DISODIUM ETHYLENEDIAMINEDIACETATE (UNII: EQL53S5L0F)
PHENYLPROPANOL (UNII: 0F897O3O4M)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TROMETHAMINE (UNII: 023C2WHX2V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10477-1384-1	1 in 1 CARTON	10/01/2019
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	10/01/2019

Labeler - Goodier Cosmetics LLC (007317209)

Establishment
Name	Address	ID/FEI	Business Operations
Goodier Cosmetics LLC		007317209	manufacture(10477-1384)