Label: BODY TIME ANTI-AGING DAY CREAM SPF 30- avobenzone, octinoxate, octisalate, oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 61979-001-59 - 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 July 21, 2014
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- Official Label (Printer Friendly)
- BODY TIME Anti-Aging Day Cream SPF 30
- Active Ingredients
- Purpose
- Use
- Warnings
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Directions
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apply liberally 15 minutes before sun exposure
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating
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Children under 6 months of age: 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 the risk, regularly uses a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
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Limit time in the sun, especially from 10 a.m. to 2 p.m.
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Wear long- sleeved shirts, pants, hats and sunglasses
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- Other Information
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Inactive Ingredients
WATER (AQUA), ISOPROPYL PALMITATE, ISOEICOSANE, HYDROXYETHYLACRYLATE/SOOIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, POTASSIUM CETYL PHOSPHATE, GLYCERIN, CETYL DIMETHICONE, ETHYHEXYL METHOXYCRYLENE, SILICA, DIMETHICOHE, POLYGLYCERYL-3 DIISOSTEARATE, CETEARYL ALCOHOL,HYDROXYMETHYL CELLULOSE, PHENOXYETHANOL, GLYCERYL STEARATE, PEG-1OO STEARATE, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN,HEXYLENE GLYCOL, TETRAHEXYLDECYL ASCORBATE, TOCOPHERYl ACETATE, BUTYLENE GLYCOL, CAMELIA OLEIFERA LEAF EXTRACT, PUNICA GRANATUM FRUIT EXTRACT.
- SPL UNCLASSIFIED SECTION
- BODY TIME Anti-Aging Day Cream SPF 30, 2 fl. 0Z (59 ml) (61979-001-59)
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INGREDIENTS AND APPEARANCE
BODY TIME ANTI-AGING DAY CREAM SPF 30
avobenzone, octinoxate, octisalate, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61979-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 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) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) GLYCERIN (UNII: PDC6A3C0OX) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) 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) POMEGRANATE (UNII: 56687D1Z4D) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61979-001-59 59 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/18/2014 Labeler - Bela Vida Holdings, LLC dba Body Time (057190712) Establishment Name Address ID/FEI Business Operations Columbia Cosmetics Manufacturing, Inc. 068267863 manufacture(61979-001)