Label: BODY TIME SUN BROAD SPECTRUM SPF30 ANTI-AGING DAY- avobenzone, octinoxate, octisalate, oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 61979-002-59 - Packager: Bela Vida Holdings, LLC dba Body Time
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 December 28, 2017
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- Drug Facts
- Active ingredients:
- Uses:
- 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.
- 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 a broad spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun especially from 10 AM to 2 PM.
- wear long-sleeved shirts, pants, hats and sunglasses
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Inactive ingredients:
WATER (AQUA), ISOPROPYL PALMITATE, ISOEICOSANE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, POTASSIUM CETYL PHOSPHATE, GLYCERIN, CETYL DIMETHICONE, ETHYHEXYL METHOXYCRYLENE, SILICA, DIMETHICONE, POLYGLYCERYL-3 DIISOSTEARATE, CETEARYL ALCOHOL, HYDROXYETHYLCELLULOSE, PHENOXYETHANOL, GLYCERYL STEARATE, PEG-100 STEARATE, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, HEXYLENE GLYCOL, TETRAHEXYLDECYL ASCORBATE, TOCOPHERYL ACETATE, BUTYLENE GLYCOL, CAMELIA OLEIFERA LEAF EXTRACT, PUNICA GRANATUM FRUIT EXTRACT.
- Other information:
- Product Label
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INGREDIENTS AND APPEARANCE
BODY TIME SUN BROAD SPECTRUM SPF30 ANTI-AGING DAY
avobenzone, octinoxate, octisalate, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61979-002 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 OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) ISOEICOSANE (UNII: AR294KAG3T) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) GLYCERIN (UNII: PDC6A3C0OX) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE (UNII: 92RU3N3Y1O) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1) PHENOXYETHANOL (UNII: HIE492ZZ3T) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) POMEGRANATE (UNII: 56687D1Z4D) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61979-002-59 1 in 1 BOX 06/08/2015 1 59 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 not final part352 06/08/2015 Labeler - Bela Vida Holdings, LLC dba Body Time (057190712)
