Label: SUN THERAPE PRO SPORT SPF-35- homosalate, octinoxate, oxybenzone, octocrylene, octisalate, avobenzone spray
- NDC Code(s): 67879-306-11, 67879-306-51
- Packager: PHARMAGEL INTERNATIONAL INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 7, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- OTHER SAFETY INFORMATION
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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
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INGREDIENTS AND APPEARANCE
SUN THERAPE PRO SPORT SPF-35
homosalate, octinoxate, oxybenzone, octocrylene, octisalate, avobenzone sprayProduct 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 Drug M020 06/10/2016 Labeler - PHARMAGEL INTERNATIONAL INC (603215182)