Label: ZINC OXIDE- daily face cream broad spectrum spf 20 lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 10477-1384-1 - Packager: Goodier Cosmetics LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated October 19, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
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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
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ZINC OXIDE
daily face cream broad spectrum spf 20 lotionProduct 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) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains 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)
