Drug Facts

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LA ROCHE-POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 ULTRA LIGHT SUNSCREEN FLUID- avobenzone, homosalate, octisalate, octocrylene and oxybenzone 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.

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Drug Facts

Active ingredients

Avobenzone 3%
Homosalate 15%
Octisalate 5%
Octocrylene 5%
Oxybenzone 6%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• higher SPF gives more sunburn protection
• retains SPF after 40 minutes of activity in the water or perspiring
• provides protection from the UVA rays that may contribute to skin damage and premature aging of the skin

Directions

• shake well before use
• apply evenly before sun exposure
• reapply as needed or after towel drying, swimming, or perspiring
• 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 and contact a Poison Control Center right away.

Inactive ingredients

water, tocopherol, styrene/acrylates copolymer, sodium dodecylbenzenesulfonate, sodium chloride, silica, polymethylsilsesquioxane, poly C10-30 alkyl acrylate, pehoxyethanol, PEG-8 laurate, PEG-30 dipolyhydroxystearate, nylon-12, methylparaben, maltodextrin, lauryl PEG/PPG-18/18 methicone, isostearyl alcohol, disteardimonium hectorite, disodium EDTA, dimethicone, diethylhexyl syringylidenemalonate, dicaprylyl carbonate, cyclopentasiloxane, cylcohexasiloxane, cassia alata leaf extract, caprylyl glycol, carpylic/capric tgriclycderide, alcohol denat.

LA ROCHE-POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 ULTRA LIGHT SUNSCREEN FLUID 
avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66382-299
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	150 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	50 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
TOCOPHEROL (UNII: R0ZB2556P8)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PEG-8 LAURATE (UNII: 762O8IWA10)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
NYLON-12 (UNII: 446U8J075B)
METHYLPARABEN (UNII: A2I8C7HI9T)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
SENNA ALATA LEAF (UNII: 4BXR6YZN92)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66382-299-01	1 in 1 CARTON	03/01/2011	06/01/2015
1		50 mL in 1 BOTTLE, PLASTIC; 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	03/01/2011	06/01/2015

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

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoires Industriels de Vichy (LIDV)		282658798	manufacture(66382-299)

Revised: 8/2019

Document Id: eac7c71c-ab26-44d4-91fa-280a3c02e460

34390-5

Set id: 68f5a47e-fc79-477a-9b91-c7426d89a3d8

Version: 2

Effective Time: 20190828