SUN THERAPE BODY SPF-35- homosalate, octinoxate, octisalate, avobenzone lotion

SUN THERAPE BODY by

Drug Labeling and Warnings

SUN THERAPE 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

Homosalate.........................10.0%

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

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

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:

WATER (AQUA), CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, TAPIOCA

STARCH, GLYCERYL STEARATE, PEG-100 STEARATE, STEARIC ACID, SIMMONDSIA

CHINENSIS (JOJOBA) SEED OIL, GLYCERIN, CETYL ALCOHOL, PHENOXYETHANOL,

FRAGRANCE (PARFUM), PROPYLENE GLYCOL, CARBOMER, STEARYL ALCOHOL,

PEG-7 GLYCERYL COCOATE, CAPRYLYL GLYCOL, POLYSORBATE 60, SODIUM

HYDROXIDE, ETHYLHEXYLGLCERIN, BHT, HEXYLENE GLYCOL, PANTHENOL, ALOE

BARBADENSIS (ALOE VERA) LEAF JUICE, BUTYLENE GLYCOL, ECHINACEA

ANGUSTIFOLIA (ECHINACEA) EXTRACT, HYDRASTIS CANADENSIS (GOLDEN

SEAL) EXTRACT, BORAGO OFFICINALIS SEED OIL, BUTYLOCTYL SALICYLATE,

COCOS NUCIFERA (COCONUT) OIL, DIMETHYLAMINOETHANOL TARTRATE,

MACADAMIA TERNIFOLIA (MACADAMIA) SEED OIL, MAGNESIUM ASCORBYL

PHOSPHATE, PERSEA GRATISSIMA (AVOCADO) OIL, ROSA CANINA (ROSE HIP)

FRUIT EXTRACT, CAPRYLIC/CAPRIC TRIGLYCERIDE, GINKGO BILOBA LEAF EXTRACT,

ACHILLEA MILLEFOLIUM (YARROW) EXTRACT, TOCOPHEROL, LIMONIUM GERBERI

EXTRACT, GLYCINE SOJA (SOYBEAN) OIL, CHLORPHENESIN, LECITHIN, PLANKTON

EXTRACT, BENZOIC ACID, SORBIC ACID

Questions or Comments?

Call toll free 800-882-4889

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUN THERAPE BODY  SPF-35
homosalate, octinoxate, octisalate, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67879-303
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10.0 g  in 100 mL
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
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3.0 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SAFFLOWER OIL (UNII: 65UEH262IS)
STARCH, TAPIOCA (UNII: 24SC3U704I)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
STEARIC ACID (UNII: 4ELV7Z65AP)
JOJOBA OIL (UNII: 724GKU717M)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PANTHENOL (UNII: WV9CM0O67Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)
GOLDENSEAL (UNII: ZW3Z11D0JV)
BORAGE OIL (UNII: F8XAG1755S)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
COCONUT OIL (UNII: Q9L0O73W7L)
DEANOL BITARTRATE (UNII: D240J05W14)
MACADAMIA OIL (UNII: 515610SU8C)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
AVOCADO OIL (UNII: 6VNO72PFC1)
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GINKGO (UNII: 19FUJ2C58T)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
TOCOPHEROL (UNII: R0ZB2556P8)
LIMONIUM GERBERI WHOLE (UNII: 2J5K7YCF9F)
SOYBEAN OIL (UNII: 241ATL177A)
CHLORPHENESIN (UNII: I670DAL4SZ)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SORBIC ACID (UNII: X045WJ989B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67879-303-51	1 in 1 BOX	06/18/2015
1	NDC: 67879-303-11	175 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)