SPECIFIC BEAUTY DAILY HYDRATING SPF 30- avobenzone,octocrylene,octinoxate,oxybenzone,octisalate lotion

SPECIFIC BEAUTY DAILY HYDRATING SPF 30 by

Drug Labeling and Warnings

SPECIFIC BEAUTY DAILY HYDRATING SPF 30 by is a Otc medication manufactured, distributed, or labeled by Somabella Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS

AVOBENZONE - 3 percent

OCTOCRYLENE - 2.4 percent

OCTINOXATE - 5 percent

OXYBENZONE - 5 percent

OCTISALATE - 5 percent

WARNINGS

WARNINGS: FOR EXTERNAL USE ONLY

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 or irritation develops and lasts.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children:  If swallowed, get medical help or contact a Poison Control Center immediately

DOSAGE & ADMINISTRATION

Children under 6 months ask a doctor.

After using Skin Brightening Serum, apply lotion to the entire face and neck.  For best results, continued use of the complete Specific Beauty regimen is recommended.

DESCRIPTION

Questions or for more information, please call: 877-358-1122

www.specificbeauty.com

Distributed by: Somabella Laboratories, LLC

247 SW ith St., #200, Miami FL 33130

Made in USA   #43703

Inactive Ingredients

WATER (AQUA), CAPRYLYL METHICONE, C12-15 ALKYL BENZOATE, BUTYLENE GLYCOL, NIACINAMIDE, STEARETH-21, CETEARYL ALCOHOL, GLYCERIN, ETHYLHEXYL METHOXYCRYLENE, ALUMINUM STARCH OCTENYL SUCCINATE, BORON NITRIDE, PHENOXYETHANOL, PHYLLANTHUS EMBLICA FRUIT EXTRACT BEHENYL ALCOHOL, POLYACRYLATE-13, POLYISOBUTENE, CETEARYL GLUCOSIDE, ARACHIDYL ALCOHOL ARACHIDYL GLUCOSIDE, XANTHAN GUM, POLYSORBATE 20,

CHLORPHENESIN, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, TOCOPHERYL ACETATE, DISODIUM EDTA, PHOSPHOLIPIDS, LINOLEIC ACID PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE.

PRINCIPAL DISPLAY PANEL

SPECIFIC beauty For multi-hued skin tones

Daily Hydrating Lotion; SPF 30

STEP 3 BRIGHTENS SKIN

UVA/UVB Protection

DERMATOLOGIST DESIGNED REGIMEN

2 FL OZ (60 mL)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPECIFIC BEAUTY DAILY HYDRATING SPF 30 
avobenzone,octocrylene,octinoxate,oxybenzone,octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52295-200
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	24 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MYRISTYL TRISILOXANE (UNII: J7960S4R1T)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
NIACINAMIDE (UNII: 25X51I8RD4)
STEARETH-21 (UNII: 53J3F32P58)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DOCOSANOL (UNII: 9G1OE216XY)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LINOLEIC ACID (UNII: 9KJL21T0QJ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52295-200-60	60 mL in 1 PACKAGE; Type 0: Not a Combination Product	01/20/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/20/2011

Labeler - Somabella Laboratories, LLC (877094925)