SUN THERAPE FACE AND BODY SPF-35- avobenzone, octinoxate, octisalate, oxybenzone lotion

SUN THERAPE FACE AND BODY by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENTS

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

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

Octisalate.............................5.0%

Oxybenzone..........................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

For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with warm 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.

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, GLYCERYL STEARATE, PEG-100 STEARATE, CETEARYL ALCOHOL, DIMETHICONE, PALMITIC ACID, CAPRYLIC/CAPRIC TRIGLYCERIDE, PHENOXYETHANOL, STEARIC ACID, 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, CAMELLIA SINENSIS (BLACK TEA) LEAF EXTRACT, ELETTARIA CARDAMOMUM SEED EXTRACT, JASMINUM OFFICINALE FLOWER/LEAF EXTRACT, ROSE EXTRACT, MYRISTIC ACID, 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 EXRACT, TOCOPHERYL ACETATE, ALOE BARBADENSIS (ALOE VERA) LEAF JUICE, UNDECYLENOYL PHENYLALANINE, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, ARACHIDIC ACID, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, BHT, ABIES BALSAMEA (BALSAM CANADA) EXTRACT, CANANGA ODORATA (YLANG) FLOWER EXTRACT, COFFEA ARABICA LEAF/SEED EXTRACT, CUCUMIS MELO CANTALUPENSIS FRUIT EXTRACT, FERULA GALBANIFLUA GUM EXTRACT, HYACINTHUS ORIENTALUS (HYACINTHUS) FLOWER EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, CYPERUS ROTUNDUS ROOT EXTRACT, ACHILLEA MILLEFOLIUM (YARROW) EXTRACT, ECHINACEA ANGUSTIFOLIA (ECHINACEA) EXTRACT, HYDRASTIS CANADENSIS (GOLDEN SEAL) EXTRACT, SIMMONDSIA CHINENSIS (JOJOBA) SEED EXTRACT, ROSA CANINA (ROSE HIP) FRUIT 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

OTHER INFORMATION

• PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN

Questions or Comments?

Call toll free 800-882-4889

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUN THERAPE FACE AND BODY  SPF-35
avobenzone, octinoxate, octisalate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67879-309
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3.0 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.0 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
PALMITIC ACID (UNII: 2V16EO95H1)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (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)
TEA LEAF (UNII: GH42T47V24)
CARDAMOM (UNII: 8BC4CUT4JL)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O)
MYRISTIC ACID (UNII: 0I3V7S25AW)
BORAGE OIL (UNII: F8XAG1755S)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
COCONUT OIL (UNII: Q9L0O73W7L)
DEANOL BITARTRATE (UNII: D240J05W14)
KOJIC ACID (UNII: 6K23F1TT52)
MACADAMIA OIL (UNII: 515610SU8C)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
NIACIN (UNII: 2679MF687A)
AVOCADO OIL (UNII: 6VNO72PFC1)
PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
UNDECYLENOYL PHENYLALANINE (UNII: 271P08C6OD)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
ARACHIDIC ACID (UNII: PQB8MJD4RB)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BALSAM FIR LEAFY TWIG (UNII: H1TFV1454Z)
CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M)
ARABICA COFFEE BEAN (UNII: 3SW678MX72)
CANTALOUPE (UNII: 8QF5D5H6UH)
GALBANUM (UNII: C690YC9N2Z)
HYACINTHUS ORIENTALIS FLOWER (UNII: Y740K1LEA3)
APPLE (UNII: B423VGH5S9)
CYPERUS ROTUNDUS ROOT (UNII: 4B51SRR959)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)
GOLDENSEAL (UNII: ZW3Z11D0JV)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
GINKGO (UNII: 19FUJ2C58T)
LIMONIUM GERBERI FLOWERING TOP (UNII: V4O4C05BJ2)
SODIUM BENZOATE (UNII: OJ245FE5EU)
LACTIC ACID (UNII: 33X04XA5AT)
UNDECYLENIC ACID (UNII: K3D86KJ24N)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)
CHLORPHENESIN (UNII: I670DAL4SZ)
FD&C RED NO. 40 (UNII: WZB9127XOA)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67879-309-51	1 in 1 BOX	06/10/2016
1	NDC: 67879-309-12	125 mL in 1 TUBE; 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	06/18/2015

Labeler - PHARMAGEL INTERNATIONAL INC (603215182)

Registrant - PHARMAGEL INTERNATIONAL INC (603215182)