SKIN SOOTHING MINERAL SUNSCREEN BROAD SPECTRUM SPF 40 SUPERGOOP- octinoxate, zinc oxide cream 
TAYLOR JAMES, LTD.

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.

----------

Skin Soothing Mineral Sunscreen SPF 40

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, Tocotrienols

Supergoop Skin Soothing Mineral Sunscreen

with Olive Polyphenols

Broad Spectrum SPF 40

2.4 fl. oz./ 71 mL

Box

Primary

SKIN SOOTHING MINERAL SUNSCREEN BROAD SPECTRUM SPF 40  SUPERGOOP
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-129
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SQUALANE (UNII: GW89575KF9)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
BLACK OLIVE (UNII: 2M6QWV94OC)  
ACAI (UNII: 46AM2VJ0AW)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
TOCOTRIENOLS (UNII: KP2MW85SSQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75936-129-021 in 1 BOX01/22/2014
1NDC:75936-129-0171 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:75936-129-041 in 1 BOX01/22/2014
2NDC:75936-129-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/22/2014
Labeler - TAYLOR JAMES, LTD. (033381850)
Registrant - TAYLOR JAMES, LTD. (033381850)
Establishment
NameAddressID/FEIBusiness Operations
Cosway Company Inc620899877manufacture(75936-129)

Revised: 12/2018
Document Id: edfbb78b-49fa-4c1f-aa56-8fa701eacd4f
Set id: ef24da08-5cb7-4319-aa78-0d9b8636fe67
Version: 6
Effective Time: 20181218
 
TAYLOR JAMES, LTD.