HYALURONIC HYDRA-FOUNDATION SPF30 400C COOL MEDIUM- titanium dioxide, octinoxate cream

Hyaluronic Hydra-Foundation SPF30 400C Cool Medium by

Drug Labeling and Warnings

Hyaluronic Hydra-Foundation SPF30 400C Cool Medium by is a Otc medication manufactured, distributed, or labeled by Luxe Art Beaute SAS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Titanium dioxide 6.505%

Octinoxate 3.9972%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external 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 occurs.

Keep out of reach of children.

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

Directions

• Apply liberally and evenly 15 minutes before sun exposure
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10 a.m. - 2 p.m.
• Wear long-sleeved shirts, pants, hats and sunglasses
• Children under 6 months of age: Ask a doctor

Other information

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

Inactive ingredients

ISODODECANE, WATER, SILICA, CAPRYLIC/CAPRIC TRIGLYCERIDE, ISOHEXADECANE, PHENYL TRIMETHICONE, SYNTHETIC FLUORPHLOGOPITE, PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, TRIMETHYLSILOXYSILICATE, DIPROPYLENE GLYCOL, GLYCERIN, NIACINAMIDE, CETYL PEG/PPG-10/1 DIMETHICONE, C13-15 ALKANE, DIISOSTEARYL MALATE, SILICA DIMETHYL SILYLATE, MAGNESIUM SULFATE, TRIETHOXYCAPRYLYLSILANE, DISTEARDIMONIUM HECTORITE, POLYGLYCERYL-4 ISOSTEARATE, ALUMINUM HYDROXIDE, CAPRYLYL GLYCOL, GLYCERYL CAPRYLATE, FRAGRANCE, ETHYLHEXYLGLYCERIN, PALMITIC ACID, DIMETHICONE, ADENOSINE, SODIUM HYALURONATE, BHT, MYRISTIC ACID, STEARIC ACID, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, TOCOPHEROL
May contain: TITANIUM DIOXIDE, IRON OXIDES

Package Labeling:

INGREDIENTS AND APPEARANCE

HYALURONIC HYDRA-FOUNDATION SPF30 400C COOL MEDIUM 
titanium dioxide, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69879-209
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	65.05 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	39.972 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISOHEXADECANE (UNII: 918X1OUF1E)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
ALMOND OIL (UNII: 66YXD4DKO9)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
GLYCERIN (UNII: PDC6A3C0OX)
NIACINAMIDE (UNII: 25X51I8RD4)
C13-15 ALKANE (UNII: 114P5I43UJ)
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PALMITIC ACID (UNII: 2V16EO95H1)
DIMETHICONE (UNII: 92RU3N3Y1O)
ADENOSINE (UNII: K72T3FS567)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MYRISTIC ACID (UNII: 0I3V7S25AW)
STEARIC ACID (UNII: 4ELV7Z65AP)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69879-209-30	1 in 1 BOX	04/01/2020
1		30 mL in 1 BOTTLE, DROPPER; 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	04/01/2020

Labeler - Luxe Art Beaute SAS (378611552)