Sunscreen Day Broad Spectrum SPF 40 Supergoop

Dosage form: cream
Ingredients: OCTINOXATE 2.25g in 30mL, ZINC OXIDE 3.03g in 30mL
Labeler: TAYLOR JAMES, LTD.
NDC Code: 75936-117

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.

Supergoop Sunscreen Day Cream

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 eyes. Rinse with water to remove.


Directions
 Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating
-Children under 6 months: Ask a doctor
-Reapply at least every 2 hours
-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 broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
· Use a water resistant sunscreen if swimming or sweating


Inactive ingredients Water, Ethylhexyl Stearate, Cyclopentasiloxane, Propanediol, Butylene Glycol, C12-15 Alkyl Benzoate, Potassium Cetyl Phosphate, Adipic Acid/Diethylene Glycol/Glycerin Crosspolymer, Isohexadecane, Cetearyl Alcohol, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ceteareth-20, Triethoxycaprylylsilane, Squalane, Xanthan Gum, Helianthus Annuus (sunflower) Seed Oil, Trisodium Ethylenediamine Dissucinate, Chlorphenesin, Ethylhexylglycerin, Oleth-3 Phosphate, Punica Granatum Seed Oil, Carthamus Tinctorius (Safflower) Seed Oil, Polysorbate 60, Citric Acid, Camellia Sinensis Leaf Extract, Olea Europaea (Olive) Fruit extract, Euterpe Oleracaea Fruit Extract, Methylisothiazolinone

Doctor T's Supergoop

Anti-aging shine free cream for face and body

Antioxidant-infused

Sunscreen Day Cream

Broad Spectrum SPF40

1 fl. oz./30 ml.

SUNSCREEN DAY BROAD SPECTRUM SPF 40  SUPERGOOP
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-117
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE2.25 g  in 30 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE3.03 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ETHYLHEXYL STEARATE 
CYCLOMETHICONE 5 
PROPANEDIOL 
1,3-BUTYLENE GLYCOL 
ALKYL (C12-15) BENZOATE 
POTASSIUM CETYL PHOSPHATE 
ISOHEXADECANE 
CETOSTEARYL ALCOHOL 
DIMETHICONE 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
PHENOXYETHANOL 
POLYOXYL 20 CETOSTEARYL ETHER 
TRIETHOXYCAPRYLYLSILANE 
SQUALANE 
XANTHAN GUM 
SUNFLOWER OIL 
TRISODIUM ETHYLENEDIAMINE DISUCCINATE 
CHLORPHENESIN 
ETHYLHEXYLGLYCERIN 
OLETH-3 PHOSPHATE 
POMEGRANATE SEED OIL 
SAFFLOWER OIL 
POLYSORBATE 60 
CITRIC ACID MONOHYDRATE 
GREEN TEA LEAF 
BLACK OLIVE 
ACAI 
METHYLISOTHIAZOLINONE 
Packaging
#Item CodePackage Description
1NDC:75936-117-011 TUBE in 1 BOX
1NDC:75936-117-0230 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/26/2012
Labeler - TAYLOR JAMES, LTD. (033381850)
Registrant - TAYLOR JAMES, LTD. (033381850)
Establishment
NameAddressID/FEIOperations
Cosway Company Inc620899877manufacture(75936-117)

Revised: 06/2013
 
TAYLOR JAMES, LTD.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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