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

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PHARMAGEL - SUN THERAPE BODY LOTION (67879-303)

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. If product is swallowed, get medical help or contact a Poison Control Center right away.

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

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SUN THERAPE BODY  SPF-35
homosalate, octinoxate, octisalate, avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67879-303
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67879-303-511 in 1 BOX06/18/2015
1NDC:67879-303-11175 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02006/18/2015
Labeler - PHARMAGEL INTERNATIONAL INC (603215182)

Revised: 1/2024
Document Id: 0e3c764d-a962-2604-e063-6394a90a066b
Set id: 2da3a65a-59c1-4f96-9be6-c4ace54597b2
Version: 7
Effective Time: 20240105
 
PHARMAGEL INTERNATIONAL INC