Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

LA ROCHE-POSAY LABORATOIRE PHARMACETIQUE HYDRAPHASE UV EYES HYDRATING SPF 29 PROTECTIVE- octinoxate and titanium dioxide lotion 
Laboratoires Industriels de Vichy (LIDV)

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.

----------

Drug Facts

Active ingredients

Octinoxate 7.5%

Titanium dioxide 5.6%

Uses

• helps prevent sunburn
• higher SPF gives more sunburn protection
• protects against UVA/UVB rays

Directions

• apply evenly before sun exposure and as needed
• children under 6 months of age: ask a doctor

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

Keep out of reach of children.

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

Inactive ingredients

water, C12-15 alkyl benzoate, isononyl isononanoate, nylon-12, cyclopentasiloxane, alcohol, denat., glycerin, propylene glycol, methylsilanol/silicate crosspolymer, polymethylsilsesquioxane, cetyl PEG/PPG-10/1 dimethicone, PEG-30 dipolyhydroxystearate, synthetic wax, polyglyceryl-4 isostearate, dimethicone, caprylic/acpric triglyceride, polyhydroxystearic acid, cetearyl alcohol, aluminum tristearate, magnesium sulfate, caprylyl glycol, mica, disodium EDTA, alumina, stearalkonium hectorite, dimethiconol, potassium cetyl phosphate, caffeine, capryloyl salicylic acid, propylene carbonate, salicylic acid

LA ROCHE-POSAY LABORATOIRE PHARMACETIQUE HYDRAPHASE UV EYES HYDRATING SPF 29 PROTECTIVE 
octinoxate and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66382-157
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 mL
Titanium dioxide (UNII: 15FIX9V2JP) (Titanium dioxide - UNII:15FIX9V2JP)	Titanium dioxide	56 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
NYLON-12 (UNII: 446U8J075B)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE (UNII: 92RU3N3Y1O)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MICA (UNII: V8A1AW0880)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALUMINUM OXIDE (UNII: LMI26O6933)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
DIMETHICONOL (70 CST) (UNII: MOT8IL21AR)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CAFFEINE (UNII: 3G6A5W338E)
CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SALICYLIC ACID (UNII: O414PZ4LPZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66382-157-01	1 in 1 CARTON	09/01/2009	06/01/2012
1		15 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	09/01/2009	06/01/2012

Labeler - Laboratoires Industriels de Vichy (LIDV) (282658798)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Industriels de Vichy (LIDV)		282658798	manufacture(66382-157)

Revised: 8/2019

Document Id: 6a8945a1-1313-4b6e-9dc7-d8eacb5f0b9e

34390-5

Set id: 55fb8663-c260-42e7-a5bf-f3fc618fbccd

Version: 4

Effective Time: 20190828