BODY TIME ANTI-AGING DAY CREAM SPF 30- avobenzone, octinoxate, octisalate, oxybenzone cream

BODY TIME Anti-Aging Day Cream SPF 30 by

Drug Labeling and Warnings

BODY TIME Anti-Aging Day Cream SPF 30 by is a Otc medication manufactured, distributed, or labeled by Bela Vida Holdings, LLC dba Body Time, Columbia Cosmetics Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BODY TIME Anti-Aging Day Cream SPF 30

Active Ingredients

Avobenzone 3.0%

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 4.0%

Purpose

Sunscreen

Use

• 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

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure

• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating

• Children under 6 months of age: Ask a doctor

• 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:

• Limit time in the sun, especially from 10 a.m. to 2 p.m.

• Wear long- sleeved shirts, pants, hats and sunglasses

Other Information

Protect the product in this container from excessive heat and direct sun

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, Berkeley, CA 94710

www.bodytime.com

BODY TIME Anti-Aging Day Cream SPF 30, 2 fl. 0Z (59 ml) (

61979-001-59)

BODY TIME

sun

Anti-Aging Day Cream

SPF 30

EST.1970

Berkeley, California

2 fl. 0Z . 59 ml.

Anti-Aging Day Cream

SPF 30

A light easily absorbed SPF day creme formulated with Antioxidants and Extracts of White Tea and Pomegranate.

INGREDIENTS AND APPEARANCE

BODY TIME ANTI-AGING DAY CREAM SPF 30 
avobenzone, octinoxate, octisalate, oxybenzone cream

Product 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)