Label: SUPER POWER SUNSCREEN MOUSSE SPF 50 SUPERGOOP- avobenzone, homosalate, octinoxate, octisalate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 75936-505-01, 75936-505-02, 75936-505-03, 75936-505-04, view more75936-505-05, 75936-505-06 - Packager: TAYLOR JAMES, LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 7, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
- Apply liberally 15 minutes before sun exposure
- Reapply after 80 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
- Children under 6 months: Ask a doctor
Sun Protection Measures Spending time in teh sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses
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INACTIVE INGREDIENT
Aluminum Starch Octenylsuccinate, Ananas Sativus (Pineapple) Fuit Extract, Bis-Hydroxyethoxypropyl Dimethicone, Butter Extract, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Cananga Odorata Flower Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Chlorphenesin, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Grandis (Grapefruit) Fruit Extract, Citrus Limon (Lemon) Peel Extract, Cocos Nucifera (Cocnut) Fruit Extract, Cocos Nucifera (Coconut) Oil, Arabica (Coffee) Seed Extract, Crambe Maritima Leaf Extract, Cucumis Melo Cantalupensis Fruit Extract, Cucumis Sativus (Cucumber) Fruit Extract, Diethylhexyl Syringylidenemalonate, Disodium EDTA, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, Hydrofluorocarbon 152A, Olea Europaea (Olive) Fruit Oil, Panthenol, Passiflora Incarnata Fruit Extract, Persea Gratissima (Avocado) Oil, Polyester-5, Potassium Cetyl Phosphate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Prunus Amygdalus Dulcis (Sweet Almond) Seed Extract, Prunus Armeniaca (Apricot) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Rose Extract, Rubus Idaeus (Raspberry) Fruit Extract, Santalum Album (Sandalwood) Extract, Simmondsia Chinesis (Jojoba) Seed Oil, Tocopherol, Trehalose, Vanilla Planifolia Fruit Extract, Water
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUPER POWER SUNSCREEN MOUSSE SPF 50 SUPERGOOP
avobenzone, homosalate, octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-505 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 kg in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 kg in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 kg in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 kg in 100 mL Inactive Ingredients Ingredient Name Strength ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) PINEAPPLE (UNII: 2A88ZO081O) BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SHEA BUTTER (UNII: K49155WL9Y) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CHLORPHENESIN (UNII: I670DAL4SZ) ORANGE PEEL (UNII: TI9T76XD44) GRAPEFRUIT (UNII: O82C39RR8C) LEMON PEEL (UNII: 72O054U628) COCONUT (UNII: 3RT3536DHY) COCONUT OIL (UNII: Q9L0O73W7L) ARABICA COFFEE BEAN (UNII: 3SW678MX72) CRAMBE MARITIMA LEAF (UNII: NO0DI2V62B) CANTALOUPE (UNII: 8QF5D5H6UH) CUCUMBER (UNII: YY7C30VXJT) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544) 1,1-DIFLUOROETHANE (UNII: 0B1U8K2ME0) OLIVE OIL (UNII: 6UYK2W1W1E) PANTHENOL (UNII: WV9CM0O67Z) PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P) AVOCADO OIL (UNII: 6VNO72PFC1) POLYESTER-5 (TG-38) (UNII: 2L9351NW8W) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) ALMOND OIL (UNII: 66YXD4DKO9) ALMOND (UNII: 3Z252A2K9G) APRICOT (UNII: 269CJD5GZ9) APPLE (UNII: B423VGH5S9) RASPBERRY (UNII: 4N14V5R27W) SANDALWOOD (UNII: 3641YW25N2) JOJOBA OIL (UNII: 724GKU717M) TOCOPHEROL (UNII: R0ZB2556P8) TREHALOSE (UNII: B8WCK70T7I) VANILLA (UNII: Q74T35078H) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-505-02 1 in 1 BOX 01/13/2017 1 NDC:75936-505-01 100 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:75936-505-06 1 in 1 BOX 02/07/2018 2 NDC:75936-505-05 50 mL in 1 CAN; Type 0: Not a Combination Product 3 NDC:75936-505-04 1 in 1 BOX 01/13/2017 3 NDC:75936-505-03 210 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 01/13/2017 Labeler - TAYLOR JAMES, LTD. (033381850) Registrant - TAYLOR JAMES, LTD. (033381850) Establishment Name Address ID/FEI Business Operations United Laboratories Manufacturing, LLC 807878116 manufacture(75936-505)
