SKIN SOOTHING MINERAL SUNSCREEN BROAD SPECTRUM SPF 40 SUPERGOOP- octinoxate, zinc oxide cream

Skin Soothing Mineral Sunscreen Broad Spectrum SPF 40 by

Drug Labeling and Warnings

Skin Soothing Mineral Sunscreen Broad Spectrum SPF 40 by is a Otc medication manufactured, distributed, or labeled by TAYLOR JAMES, LTD., Cosway Company Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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

PRINCIPAL DISPLAY PANEL

Supergoop Skin Soothing Mineral Sunscreen

with Olive Polyphenols

Broad Spectrum SPF 40

2.4 fl. oz./ 71 mL

INGREDIENTS AND APPEARANCE

SKIN SOOTHING MINERAL SUNSCREEN BROAD SPECTRUM SPF 40  SUPERGOOP
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-129
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	10.1 g  in 100 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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-129-02	1 in 1 BOX	01/22/2014
1	NDC: 75936-129-01	71 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 75936-129-04	1 in 1 BOX	01/22/2014
2	NDC: 75936-129-03	30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/22/2014

Labeler - TAYLOR JAMES, LTD. (033381850)

Registrant - TAYLOR JAMES, LTD. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
Cosway Company Inc		620899877	manufacture(75936-129)