JUST ENOUGH SPF 15 TINTED MOISTURIZER IVORY IS BEAUTIFUL- octinoxate, titanium dioxide, octisalate cream

Just Enough SPF 15 Tinted Moisturizer by

Drug Labeling and Warnings

Just Enough SPF 15 Tinted Moisturizer by is a Otc medication manufactured, distributed, or labeled by Bona Fide Beauty Lab PS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• apply liberally 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours

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:

INGREDIENTS AND APPEARANCE

JUST ENOUGH SPF 15 TINTED MOISTURIZER  IVORY IS BEAUTIFUL
octinoxate, titanium dioxide, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72112-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	55 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	27 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72112-017-01	1 in 1 CARTON	06/01/2018
1		30 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
OTC monograph not final	part352	06/01/2018

Labeler - Bona Fide Beauty Lab PS LLC (064526749)