BOTANICAL EFFECTS MOISTURIZER SPF 30- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Botanical Effects Moisturizer SPF 30 by

Drug Labeling and Warnings

Botanical Effects Moisturizer SPF 30 by is a Otc medication manufactured, distributed, or labeled by Mary Kay Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

UVA/UVB Protection

Warnings:

For external use only, not to be swallowed.

Avoid contact with eyes.

Discontiunue use if signs of rash or irritation appear.

Keep out of reach of children.

Do not stay too long in the sun, even while using a sunscreen product.

Overexposure to the sun is dangerous.

Contains Benzophenone-3.

Directions:

Apply liberally prior to sun exposure.

Reapply frequently to maintain protection.

Ingredients:

AQUA, HOMOSALATE, ALCOHOL DENAT., CYCLOPENTASILOXANE, BIOSACCHARIDE GUM-1, BENZOPHENONE-3, ETHYLHEXYL SALICYLATE, BUTYLENE GLYCOL, BUTYL METHOXYDIBENZOYLMETHANE, OCTOCRYLENE, ALOE BARBADENSIS LEAF EXTRACT, HYLOCEREUS UNDATUS FRUIT EXTRACT, DIPOTASSIUM GLYCYRRHIZATE, GLYCERIN, CYCLOHEXASILOXANE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CARBOMER, SODIUM ACRYLATES CROSSPOLYMER-2, METHYLDIHYDROJASMONATE, ISOBUTYL METHYL TETRAHYDROPYRANOL, SILICA, DISODIUM EDTA, ETHYLENE BRASSYLATE, ETHYLHEXYLGLYCERIN, HYDROXYPROPYL CYCLODEXTRIN, ETHYL LINALOOL, TRIETHANOLAMINE, CYCLAMEN ALDEHYDE, GAMMA-UNDECALACTONE, METHYLENEDIOXYPHENYL METHYLPROPANAL, CITRONELLYL ACETATE, METHYL DIMETHYLMETHYLENECYCLOHEXANE CARBOXYLATE, CITRIC ACID, SODIUM BENZOATE, IODOPROPYNYL BUTYLCARBAMATE, PHENOXYETHANOL.

Principal Display Panel - 50 mL Carton

mary kay

BOTANICAL EFFECTS

UVA

HIGH PROTECTION

MOISTURIZING LOTION WITH SPF 30

50 mL

INGREDIENTS AND APPEARANCE

BOTANICAL EFFECTS MOISTURIZER SPF 30 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51531-4850
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	9 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.75 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
GLYCERIN (UNII: PDC6A3C0OX)
METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYLOCEREUS UNDATUS FRUIT (UNII: WUG58TD53X)
2-ISOBUTYL-4-METHYLTETRAHYDROPYRAN-4-OL (UNII: VK5ZHH2T3F)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HYDROXYPROPYL .ALPHA.-CYCLODEXTRIN (UNII: ZFR0T80O4Y)
ETHYL LINALOOL (UNII: SF2JS9GF5T)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
TROLAMINE (UNII: 9O3K93S3TK)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLAMEN ALDEHYDE (UNII: 4U37UX0E1E)
.GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL)
3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA)
CITRONELLYL ACETATE (UNII: IZ420RT3OY)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51531-4850-7	1 in 1 CARTON	08/21/2014
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
export only		08/21/2014

Labeler - Mary Kay Inc. (049994452)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		103978839	manufacture(51531-4850)

Establishment
Name	Address	ID/FEI	Business Operations
Mary Kay Inc.		081158134	manufacture(51531-4850)