Label: RECAPTURE 360 DAY PLUS IR DEFENSE- avobenzone, octocrylene, and octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70550-001-14, 70550-001-49, 70550-001-69, 70550-001-70 - Packager: Atlantic Coast Media Group, LLC.
- 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 January 24, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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Directions
- Apply liberally 15 minutes before sun exposure
- Use a water resistant sunscreen if swimming or sweating
- Reapply at least every 2 hours
- Children under 6 months: Ask a doctor
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Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with a 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
- Other information
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Inactive ingredients
Water, Isododecane, Cyclopentasiloxane, Cetyl Alcohol, Butylene Glycol, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Sodium Potassium Aluminum Silicate, Ethylhexyl Methoxycrylene, Xylitylglucoside, Diethylhexyl Syringylidenemalonate, Phormidium Persicinum Extract, Laminaria Digitata Extract, Simmondsia Chinensis (Jojoba) Seed Extract, Polygonum Aviculare Extract, Methylglucoside Phosphate, Copper Lysinate/Prolinate, Aminopropyl Ascorbyl Phosphate, Micrococcus Lysate, Bakuchiol, Lecithin, Ergothioneine, Tocopheryl Acetate, Butyrospermum Parkii (Shea) Butter, Cichorium Intybus (Chicory) Root Extract, Pyrus Malus (Apple) Fruit Extract, Prunus Armeniaca (Apricot) Fruit Extract, Jasminum Officinale (Jasmine) Flower/Leaf Extract, Coffea Arabica (Coffee) Leaf/Seed Extract, Cinnamomum Cassia Bark Extract, Camellia Sinensis Leaf Extract, Arabidopsis Thaliana Extract, Glycine Soja (Soybean) Oil, Eugenia Caryophyllus (Clove) Flower Extract, Cucumis Melo Cantalupensis Fruit Extract, Orchis Mascula Flower Extract, Cananga Odorata Flower Extract, Rose Extract, Stearyl Dimethicone, Sea Water, Octadecane, Cetearyl Alcohol, Silica, Anhydroxylitol, Coco-Glucoside, Carbomer, Ethylhexylglycerin, Aminomethyl Propanol, Xylitol, Sodium Dehydroacetate, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Caprylic/Capric Triglyceride, Calcium Hydroxymethionine, 3-Aminopropane Sulfonic Acid, Polysorbate 20, Disodium EDTA, Hydroxyethylcellulose, Pentylene Glycol, Phenoxyethanol, Chlorphenesin, Benzyl Alcohol, Mica, Tin Oxide, Titanium Dioxide
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL - Jar Label
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INGREDIENTS AND APPEARANCE
RECAPTURE 360 DAY PLUS IR DEFENSE
avobenzone, octocrylene, and octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70550-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 42 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL Inactive Ingredients Ingredient Name Strength ISODODECANE (UNII: A8289P68Y2) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CETYL ALCOHOL (UNII: 936JST6JCN) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) XYLITYLGLUCOSIDE (UNII: O0IEZ166FB) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) PHORMIDIUM PERSICINUM (UNII: ZA983U4810) LAMINARIA DIGITATA (UNII: 15E7C67EE8) SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H) POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) AMINOPROPYL ASCORBYL PHOSPHATE (UNII: 290O2PQ83R) BAKUCHIOL (UNII: OT12HJU3AR) ERGOTHIONEINE (UNII: BDZ3DQM98W) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SHEA BUTTER (UNII: K49155WL9Y) CHICORY ROOT (UNII: 090CTY533N) APPLE (UNII: B423VGH5S9) APRICOT (UNII: 269CJD5GZ9) JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432) ARABICA COFFEE BEAN (UNII: 3SW678MX72) CHINESE CINNAMON (UNII: WS4CQ062KM) GREEN TEA LEAF (UNII: W2ZU1RY8B0) ARABIDOPSIS THALIANA (UNII: AI3L60HQ81) SOYBEAN OIL (UNII: 241ATL177A) CLOVE (UNII: K48IKT5321) CANTALOUPE (UNII: 8QF5D5H6UH) ORCHIS MASCULA FLOWER (UNII: 6H1JQK35LA) CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M) STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY) SODIUM CHLORIDE (UNII: 451W47IQ8X) OCTADECANE (UNII: N102P6HAIU) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ANHYDROXYLITOL (UNII: 8XWR7NN42F) COCO GLUCOSIDE (UNII: ICS790225B) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) XYLITOL (UNII: VCQ006KQ1E) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF) DESMENINOL CALCIUM (UNII: 1VK0YS654L) TRAMIPROSATE (UNII: 5K8EAX0G53) POLYSORBATE 20 (UNII: 7T1F30V5YH) EDETATE DISODIUM (UNII: 7FLD91C86K) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) PENTYLENE GLYCOL (UNII: 50C1307PZG) PHENOXYETHANOL (UNII: HIE492ZZ3T) CHLORPHENESIN (UNII: I670DAL4SZ) BENZYL ALCOHOL (UNII: LKG8494WBH) MICA (UNII: V8A1AW0880) STANNIC OXIDE (UNII: KM7N50LOS6) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70550-001-69 1 in 1 CARTON 03/01/2015 1 30 mL in 1 JAR; Type 0: Not a Combination Product 2 NDC:70550-001-14 1 in 1 CARTON 03/01/2015 2 30 mL in 1 JAR; Type 0: Not a Combination Product 3 NDC:70550-001-49 1 in 1 CARTON 03/01/2015 3 15 mL in 1 JAR; Type 0: Not a Combination Product 4 NDC:70550-001-70 1 in 1 CARTON 03/01/2015 4 45 mL in 1 JAR; 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 03/01/2015 Labeler - Atlantic Coast Media Group, LLC. (800337946)
