INTENSIVE AGE DEFYING HYDRATING COMPLEX SPF 25- homosalate, octinoxate, oxybenzone, avobenzone cream

Intensive Age Defying Hydrating Complex SPF 25 by

Drug Labeling and Warnings

Intensive Age Defying Hydrating Complex SPF 25 by is a Otc medication manufactured, distributed, or labeled by June Jacobs Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Homosalate 10.0%

Octinoxate 7.5%

Oxybenzone 5.0%

Avobenzone 3.0%

PURPOSE

Sunscreen

INDICATIONS & USAGE

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

Warnings

For external use only

DO NOT USE

Do not use on damaged or broken skin

WHEN USING

When using this product keep out of eyes.

Rinse with water to remove.

STOP USE

Stop use and ask a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions ■Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with 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

■ Reapply at least every 2 hours ■ Use a water resistant sunscreen if swimming or sweating ■ Children under 6 months: Ask a doctor

INACTIVE INGREDIENT

Inactive ingredients

Water/Aqua/Eau, Water/ Aqua, Rosa Damascena Extract, Ceteareth-20, Cyclopentasiloxane, Glycerin, Cetearyl Alcohol, Caprylyl Glycol, HDI/Trimethylol Hexyllactone Crosspolymer, Carbomer, Punica Granatum Seed Oil, Sodium Lactate, Phoenix Dactylifera (Date) Fruit Extract, Caramel, Caprylhydroxamic Acid, Allantoin, Sodium Hydroxide, Panthenol, Sodium Phytate, Chlorella Vulgaris Extract, Lycium Barbarum Fruit Extract, Punica Granatum Extract, Vitis Vinifera (Grape) Seed Extract, Aspalathus Linearis Leaf Extract, Phenoxyethano, Arnica Montana Flower Extract, Oryza Sativa (Rice) Bran Extract, Glycine Soja (Soybean) Germ Extract, Silica, Leuconostoc/Radish Root Ferment Filtrate, Rosa Damascena Flower Oil, Hydrolyzed Elastin, Soluble Collagen, Alcohol, Camellia Sinensis Leaf Extract, Sodium Benzoate, Tetrasodium EDTA, Benzyl Benzoate, Citronellol, Geraniol.

OTHER SAFETY INFORMATION

Other information ■ Protect this product from excessive heat and direct sun

QUESTIONS

Questions or comments? Call toll free 1-866-JUNEJACOBS ■ www.JUNEJACOBS.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INTENSIVE AGE DEFYING HYDRATING COMPLEX SPF 25 
homosalate, octinoxate, oxybenzone, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65278-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.549 g  in 47.32 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.4196 g  in 47.32 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	4.732 g  in 47.32 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2.366 g  in 47.32 g

Inactive Ingredients
Ingredient Name	Strength
PANTHENOL (UNII: WV9CM0O67Z)
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
RICE BRAN (UNII: R60QEP13IC)
HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW) (UNII: ZR28QKN0WT)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
PHYTATE SODIUM (UNII: 88496G1ERL)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)
ALCOHOL (UNII: 3K9958V90M)
ROSA DAMASCENA FLOWERING TOP (UNII: 21W82Q764G)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6)
ALLANTOIN (UNII: 344S277G0Z)
CARAMEL (UNII: T9D99G2B1R)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
EDETATE SODIUM (UNII: MP1J8420LU)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
GERANIOL (UNII: L837108USY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHLORELLA VULGARIS (UNII: RYQ4R60M02)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
BENZYL BENZOATE (UNII: N863NB338G)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
SOYBEAN GERM (UNII: JBW2VHD14M)
COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W)
WATER (UNII: 059QF0KO0R)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LACTATE, L- (UNII: P2Y1C6M9PS)
DATE (UNII: H3O7QI5HY7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65278-103-01	47.32 g in 1 TUBE; Type 0: Not a Combination Product	10/23/2014
2	NDC: 65278-103-02	47.32 g in 1 CARTON; Type 0: Not a Combination Product	10/23/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/23/2014

Labeler - June Jacobs Labs, LLC (082439410)

Establishment
Name	Address	ID/FEI	Business Operations
June Jacobs Labs, LLC		122610681	manufacture(65278-103)