ACTIVE INGREDIENTS

Octinoxate.....................7.5%

Octisalate ...................5.0%
Oxybenzone..................3.0%

Avobenzone................3.0%

PURPOSE

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

WARNINGS

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
• Stop use and ask doctor if rash occurs

• Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions For Sunscreen Use:

• Apply liberally and evenly 15 minutes before sun exposure
• 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
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• Children under 6 months: Ask a doctor

INACTIVE INGREDIENTS:

WATER (AQUA), ETHYLHEXYL PALMITATE, PROPYLENE GLYCOL, CLYCERYL STEARATE, PEG-100 STEARATE, CETEARYL ALCOHOL, STEARIC ACID, DIMETHICONE, FRAGRANCE (PARFUM), PHENOXYETHANOL, MYRISTYL MYRISTATE, CAPRYLYL GLYCOL, HYDROXYETHYLCELLULOSE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ETHYLHEXYLGLYCERIN, ALLANTOIN, HEXYLENE GLYCOL, MYRISTYL LAURATE, PANTHENOL, TETRASODIUM EDTA, AMINOMETHYL PROPANOL, GLYCERIN, GLYCOLIC ACID, BUTYLENE GLYCOL, MORUS ALBA LEAF EXTRACT, BORAGO OFFICINALIS SEED OIL, BUTYLOCTYL SALICYLATE, COCOS NUCIFERA (COCONUT) OIL, DIMETHYLAMINOETHANOL TARTRATE, KOJIC ACID, MACADAMIA TERNIFOLIA (MACADAMIA) SEED OIL, MAGNESIUM ASCORBYL PHOSPHATE, NIACIN, PERSEA GRATISSIMA (AVOCADO) OIL, PHYLLANTHUS EMBLICA FRUIT EXTRACT, ROSA CANINA (ROSE HIP) FRUIT EXTRACT, TOCOPHERYL ACETATE, ALOE BARBADENSIS (ALOE VERA) LEAF JUICE, UNDECYLENOYL PHENYLALANINE, CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, CYPERUS ROTUNDUS ROOT EXTRACT, ACHILLEA MILLEFOLIUM (YARROW) EXTRACT, ECHINACEA ANGUSTIFOLIA (ECHINACEA) EXTRACT, HYDRASTIS CANADENSIS (GOLDENSEAL) EXTRACT, SIMMONDSIA CHINENSIS (JOJOBA) SEED EXTRACT, GINKGO BILOBA LEAF EXTRACT, LIMONIUM GERBERI EXTRACT, SODIUM BENZOATE, LACTIC ACID, UNDECYLENIC ACID, POTASSIUM SORBATE, YELLOW 6 (CI 15985), LECITHIN, PLANKTON EXTRACT, CHLORPHENESIN, RED 40 (CI 16035), BENZOIC ACID, SORBIC ACID

Questions or Comments?

Call toll free 855-292-3483

iSun Therape Pro Sport Face-Body_Label_32oz.jpg

SUN THERAPE PRO SPORT FACE AND BODY SPF-35
octinoxate, octisalate, oxybenzone, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67879-305
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 g in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
MACADAMIA OIL (UNII: 515610SU8C)
SODIUM BENZOATE (UNII: OJ245FE5EU)
LACTIC ACID (UNII: 33X04XA5AT)
UNDECYLENIC ACID (UNII: K3D86KJ24N)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)
NIACIN (UNII: 2679MF687A)
AVOCADO OIL (UNII: 6VNO72PFC1)
PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
UNDECYLENOYL PHENYLALANINE (UNII: 271P08C6OD)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CYPERUS ROTUNDUS ROOT (UNII: 4B51SRR959)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)
GOLDENSEAL (UNII: ZW3Z11D0JV)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
GINKGO (UNII: 19FUJ2C58T)
LIMONIUM GERBERI WHOLE (UNII: 2J5K7YCF9F)
CHLORPHENESIN (UNII: I670DAL4SZ)
FD&C RED NO. 40 (UNII: WZB9127XOA)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SORBIC ACID (UNII: X045WJ989B)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALLANTOIN (UNII: 344S277G0Z)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
MYRISTYL LAURATE (UNII: 58U0NZN2BT)
PANTHENOL (UNII: WV9CM0O67Z)
EDETATE SODIUM (UNII: MP1J8420LU)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCOLIC ACID (UNII: 0WT12SX38S)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MORUS ALBA LEAF (UNII: M8YIA49Q2P)
BORAGE OIL (UNII: F8XAG1755S)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
COCONUT OIL (UNII: Q9L0O73W7L)
DEANOL BITARTRATE (UNII: D240J05W14)
KOJIC ACID (UNII: 6K23F1TT52)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:67879-305-13	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/10/2016
2	NDC:67879-305-52	1 in 1 BOX	06/10/2016
2	NDC:67879-305-12	125 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	06/09/2016

Labeler - PHARMAGEL INTERNATIONAL INC (603215182)