SUN THERAPE PRO SPORT SPF-35- homosalate, octinoxate, oxybenzone, octocrylene, octisalate, avobenzone spray

SUN THERAPE PRO SPORT by

Drug Labeling and Warnings

SUN THERAPE PRO SPORT by is a Otc medication manufactured, distributed, or labeled by PHARMAGEL INTERNATIONAL INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Homosalate..................15%
Octinoxate.....................7.5%
Oxybenzone..................6.0%

Octocrylene................5.5%
Octisalate ...................5.0%
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

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

OTHER SAFETY INFORMATION

Flammable: Keep away from flame or high heat. Avoid spraying in eyes. Contents under pressure. DO not puncture or incinerate. DO not store at temperature above 120ºF.

Other Information
Protect the product in this container from excessive heat
and direct sun

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:

ALCOHOL DENAT, POLYESTER-8, ACRYLATES/OCTYLACRYLAMIDE COPOLYMER, ETHOXYDIGLYCOL, COCOS NUCIFERA (COCONUT) OIL, BUTYLENE GLYCOL, TRISILOXANE, FRAGRANCE (PARFUM), TOCOPHERYL ACETATE, DIMETHICONE, POLYESTER-10, PROPYLENE GLYCOL DIBENZOATE, GARDENIA TAHITENSIS (TIARE) FLOWER, BORAGO OFFICINALIS SEED OIL, BUTYLOCTYL SALICYLATE, MACADAMIA TERNIFOLIA (MACADAMIA) SEED OIL, PANTHENOL, PERSEA GRATISSIMA (AVOCADO) OIL, TETRAHEXYLDECYL ASCORBATE, WATER (AQUA), SIMMONDSIA CHINENSIS (JOJOBA) SEED EXTRACT, ALOE BARBADENSIS LEAF JUICE, PHENOXYETHANOL, DIMETHYLAMINOETHANOL TARTRATE, ROSA CANINA (ROSE HIP) FRUIT EXTRACT, CAPRYLIC/CAPRIC TRIGLYCERIDE, CHLORPHENESIN, BENZOIC ACID, SORBIC ACID, ACHILLEA MILLEFOLIUM (YARROW) EXTRACT, ECHINACEA ANGUSTIFOLIA (ECHINACEA) EXTRACT, HYDRASTIS CANADENSIS (GOLDEN SEAL) EXTRACT, LIMONIUM GERBERI EXTRACT, LECITHIN PLANKTON EXTRACT, CITRIC ACID, SODIUM BENZOATE

Questions or Comments?

Call toll free 800-882-4889

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUN THERAPE PRO SPORT  SPF-35
homosalate, octinoxate, oxybenzone, octocrylene, octisalate, avobenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67879-306
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5.5 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

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
OCTYL ACRYLATE (UNII: EJN94319DN)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
COCONUT OIL (UNII: Q9L0O73W7L)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRISILOXANE (UNII: 9G1ZW13R0G)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYESTER-10 (UNII: 212N9O2MMZ)
PROPYLENE GLYCOL DIBENZOATE (UNII: EQY32Z1AN4)
GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)
BORAGE OIL (UNII: F8XAG1755S)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
MACADAMIA OIL (UNII: 515610SU8C)
PANTHENOL (UNII: WV9CM0O67Z)
AVOCADO OIL (UNII: 6VNO72PFC1)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
WATER (UNII: 059QF0KO0R)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DEANOL BITARTRATE (UNII: D240J05W14)
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CHLORPHENESIN (UNII: I670DAL4SZ)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SORBIC ACID (UNII: X045WJ989B)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)
HYDRASTIS CANADENSIS WHOLE (UNII: R763EBH88T)
LIMONIUM GERBERI WHOLE (UNII: 2J5K7YCF9F)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67879-306-51	1 in 1 BOX	06/10/2016
1	NDC: 67879-306-11	125 mL in 1 BOTTLE, SPRAY; 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	06/10/2016

Labeler - PHARMAGEL INTERNATIONAL INC (603215182)

Registrant - PHARMAGEL INTERNATIONAL INC (603215182)