Label: ADVANCED ANTI-AGING EYE BROAD SPECTRUM SPF 37 SUPERGOOP- octinoxate, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 75936-120-01, 75936-120-02, 75936-120-03 - Packager: TAYLOR JAMES, LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 November 12, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active Ingredients Purpose
Octinoxate 7.5% Sunscreen
Zinc Oxide 10.1% Sunscreen
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
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Stop use and ask a doctor if rash occurs
Warnings
For external use only
Do not use on damaged or broken skin.
When using this product keep out of eye. Rinse with water to remove.
Directions Apply Liberally 15 minutes before sun exposure
Use a water resistant if swimming or sweating
Reapply at least every 2 hours
Children under 6 months: Ask a doctor
Sun Protection MeasuresSpending time in the sun increases your risk of early skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF calue of 15 or higher and other sun protection measures including:
Limit time in the sun, especially from 10 a.m.-2p.m.
Wear long-sleeved shirts, pants, hats, and sunglasses
Water, Ethylhexyl Stearate, Cyclopentasiloxane, Propanediol, Butylene Glycol, C12-15 Alkyl Benzoate, Potassium Cetyl Phosphate, Adipic Acid/Diethylene Glycol/Glycerin Crosspolymer, Isohexadecane, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Mica, Phenoxyethanol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Imperata Cylindrica Root Extract, Titanium Dioxide, Ceteareth-20, Squalane, Glycerin, Triethoxycaprylylsilane, Xanthan Gum, Helianthus Annuus (Sunflower) Seed Oil, Polysorbate 60, Trisodium Ethylene Disuccinate, Chlorphenesin, Citric Acid, Dimethicone, Dipotassium Glycyrrhizate, Ethylhexylglycerin, Oleth-3 Phosphate, PEG-8, Punica Granatum Seed Oil, Avena Sativa (Oat) Peptide, Silica, Camellia Sinensis Leaf Extract, Carbomer, Olea Europaea (Olive) Fruit Extract, Euterpe Oleracea Fruit Extract, Methylisothiazolinone, Tocotrienols, Lauroyl Lysine.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ADVANCED ANTI-AGING EYE BROAD SPECTRUM SPF 37 SUPERGOOP
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-120 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 10.1 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PROPANEDIOL (UNII: 5965N8W85T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) ISOHEXADECANE (UNII: 918X1OUF1E) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) MICA (UNII: V8A1AW0880) PHENOXYETHANOL (UNII: HIE492ZZ3T) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) SQUALANE (UNII: GW89575KF9) GLYCERIN (UNII: PDC6A3C0OX) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) XANTHAN GUM (UNII: TTV12P4NEE) SUNFLOWER OIL (UNII: 3W1JG795YI) POLYSORBATE 60 (UNII: CAL22UVI4M) TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) CHLORPHENESIN (UNII: I670DAL4SZ) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6) SAFFLOWER OIL (UNII: 65UEH262IS) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) BLACK OLIVE (UNII: 2M6QWV94OC) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) TOCOTRIENOLS (UNII: KP2MW85SSQ) LAUROYL LYSINE (UNII: 113171Q70B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-120-02 1 in 1 CARTON 01/02/2013 1 NDC:75936-120-01 15 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:75936-120-03 2 mL in 1 TUBE; Type 0: Not a Combination Product 01/02/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/02/2013 Labeler - TAYLOR JAMES, LTD. (033381850) Registrant - TAYLOR JAMES, LTD. (033381850) Establishment Name Address ID/FEI Business Operations Cosway Company, Inc. 052400223 manufacture(75936-120)
