FABULOUS FACE SPF 15- avobenzone, homosalate, oxybenzone lotion

fabulous face by

Drug Labeling and Warnings

fabulous face by is a Otc medication manufactured, distributed, or labeled by Bliss World LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Drug Facts

Active ingredients

Avobenzone 3%   Homosalate 8%   Oxybenzone 3.5%

Purpose

Purposes

Sunscreen

Keep Out of Reach of Children

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

Uses

Uses

• helps prevent sunburn
• higher SPF gives more sunburn protection
  

Warnings

Warnings

For external use only

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

Stop use and ask a doctor if rash or irritation develops and lasts .

Directions

Directions

• Apply liberally 30 minutes before sun exposure
• Children under 6 months of age: ask a doctor
• Reapply as needed or after towel drying, swimming or perspiring

Other information

Other information

Reports of serious side effects associated with use of the product can be sent to: 75 Varick St. 10th floor, New York, New York 10013

Inactive Ingredients

Inactive ingredients

water, PPG-3 benzyl ether myristate, butylene glycol, cyclopentasiloxane, cetyl alcohol, dimethicone, glyceryl stearate, diethylhexyl 2,6-naphthalate, lactobacillus/dipteryx odorata seed fermented filtrate, dimethicone crosspolymer, PEG-75 stearate, carbomer, glycerin, chlorphenesin, ceteth-20, steareth-20, 1,2-hexanediol, capryly glycol, sodium hydroxide, potassium sorbate, sodium benzoate, ascorbic acid polypeptide, sodium PCA, urea, helianthus annus (sunflower) seed oil, disodium EDTA, pantothenic acid/yeast polypeptide, xanthan gum, fragrance, zea mays (corn) oil, polyquaternium-51, trehalose, tocopherol/wheat polypeptides, saccharomyces/copper ferment, saccharomyces/iron ferment, saccharomyces/magnesium ferment, saccharomyces/silicon ferment, saccharomyces/zinc ferment, leuconostac/radish root ferment filtrate, sesamum indicum (sesame) seed oil, phenoxyethanol, macademia integrifolia seed oil, lecithin, litchi chinensis pericarp extract, olea europaea (olive) fruit oil, methylisothiazolinone, daucus carota sativa (carrot) root, retinyl palmitate, sodium hyaluronate, triacetin, tropolone, benzoic acid, lepidium sativum sprout extract, mica, titanium dioxide

Package Label

bliss

from our spa to your skin

all skin types

fabulous face lotion with spf 15

lightweight, non-greasy formula

delivers essential vitamins, minerals and omegas    illuminates skin with phytonutrients

SPF 15 UVB UVA PA++

50 mL/1.7 fl oz

bliss Dist. Bliss   New York, NY 10013 USA  

London MA3 600 UK    Made in USA - 1003-02270   blissworld.com

INGREDIENTS AND APPEARANCE

FABULOUS FACE  SPF 15
avobenzone, homosalate, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67038-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	4 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1.75 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PPG-3 BENZYL ETHER MYRISTATE (UNII: 8075L58MKO)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
DIPTERYX ODORATA SEED (UNII: D43A5L1U6L)
DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)
PEG-75 STEARATE (UNII: OT38R0N74H)
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)
GLYCERIN (UNII: PDC6A3C0OX)
CHLORPHENESIN (UNII: I670DAL4SZ)
CETETH-20 (UNII: I835H2IHHX)
STEARETH-20 (UNII: L0Q8IK9E08)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
UREA (UNII: 8W8T17847W)
SUNFLOWER OIL (UNII: 3W1JG795YI)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PANTOTHENIC ACID (UNII: 19F5HK2737)
XANTHAN GUM (UNII: TTV12P4NEE)
CORN OIL (UNII: 8470G57WFM)
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 4:1) (UNII: X8Q92E1CPM)
TREHALOSE (UNII: B8WCK70T7I)
TOCOPHEROL (UNII: R0ZB2556P8)
YEAST (UNII: 3NY3SM6B8U)
WHEAT (UNII: 4J2I0SN84Y)
RADISH (UNII: EM5RP35463)
SESAME OIL (UNII: QX10HYY4QV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MACADAMIA OIL (UNII: 515610SU8C)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
LITCHI FRUIT (UNII: Y5P61KP51E)
OLIVE OIL (UNII: 6UYK2W1W1E)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CARROT (UNII: L56Z1JK48B)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TRIACETIN (UNII: XHX3C3X673)
TROPOLONE (UNII: 7L6DL16P1T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
GARDEN CRESS SPROUT (UNII: PWQ18YNR62)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67038-105-50	15 mL in 1 TUBE
2	NDC: 67038-105-51	50 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/01/2011

Labeler - Bliss World LLC (077427396)

Registrant - Bliss World LLC (077427396)