JUST ENOUGH SPF 15 TINTED MOISTURIZER GOLDEN BROWN IS BEAUTIFUL- octinoxate, titanium dioxide, octisalate cream 
Bona Fide Beauty Lab PS LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Just Enough SPF 15 Tinted Moisturizer Golden Brown is Beautiful

Drug Facts

Active ingredients

Ethylhexyl Methoxycinnamate (5.5%)

Titanium Dioxide (Nano) 2.7%

Ethylhexyl Salicylate 3.0%

Purpose

Sunscreen

Uses

Helps prevent sunburn Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early sking aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Warnings

For Exteranl 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 occur.

Keep out of reach of children.

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

Directions

For sunscreen use:

Other information

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

Inacitive Ingredients:

Water (Aqua), Ethylhexyl Methoxycinnamate, Cetearyl Alcohol, Ethylhexyl Salicylate, Titanium Dioxide, Peg-40 Castor Oil, Cyclopentasiloxane, Xylitylglucoside, Polyglyceryl-4 Isostearate, Hydrogenated Polyisobutene, Magnesium Aluminum Silicate, Cetyl Peg/Ppg-10/1 Dimethicone, Hexyl Laurate, Anhydroxylitol, Tribehenin, Caprylyl Glycol, Xylitol, Xanthan Gum, Hydorxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Galactoarabinan, GLucose, Triethoxycaprylylsilane, Squalane, Aleurites Moluccana (Kukui) Seed Oil, Flavor (Aroma), Vaccinium Angustifolium (Blueberry) Fruit Extract, Cocos Nucifera (Coconut) Oil, Glycerin, Tetrasodium Edta, Polysorbate 60, Camellia Sinensis Leaf (Green Tea) Extract, Bht, Sorbitan Isostearate, Hibiscus Sabdariffa Flower Extract, Tocopherol, Potassium Sorbate. MAY CONTAIN (+/-): Iron Oxides (CI 77491), Iran Oxides (CI 77492), Iron Oxides (CI 77499), Titanium Dioxide (CI 77891).

Package Labeling:

Outer Package

JUST ENOUGH SPF 15 TINTED MOISTURIZER GOLDEN  BROWN IS BEAUTIFUL
octinoxate, titanium dioxide, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72112-016
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE55 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE27 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
ANHYDROXYLITOL (UNII: 8XWR7NN42F)  
TRIBEHENIN (UNII: 8OC9U7TQZ0)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
XYLITOL (UNII: VCQ006KQ1E)  
XANTHAN GUM (UNII: TTV12P4NEE)  
GALACTOARABINAN (UNII: SL4SX1O487)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SQUALANE (UNII: GW89575KF9)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
LOWBUSH BLUEBERRY (UNII: G90PX41VP0)  
COCONUT OIL (UNII: Q9L0O73W7L)  
GLYCERIN (UNII: PDC6A3C0OX)  
EDETATE SODIUM (UNII: MP1J8420LU)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
TOCOPHEROL (UNII: R0ZB2556P8)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72112-016-011 in 1 CARTON06/01/2018
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/2018
Labeler - Bona Fide Beauty Lab PS LLC (064526749)

Revised: 4/2018
Document Id: 6a0c02df-2e20-b86d-e053-2a91aa0a832d
Set id: 45bc6928-2251-4639-8dfe-5bd8fabfdac7
Version: 1
Effective Time: 20180417
 
Bona Fide Beauty Lab PS LLC