LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS SX DAILY MOISTURIZING SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone, ecamsule and octocrylene cream

La Roche Posay Laboratoire Dermatologique Anthelios SX Daily Moisturizing Sunscreen Broad Spectrum SPF 15 by

Drug Labeling and Warnings

La Roche Posay Laboratoire Dermatologique Anthelios SX Daily Moisturizing Sunscreen Broad Spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, DPT Laboratories, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 2%

Ecamsule 2%

Octocrylene 10%

Purpose

Sunscreen

Uses

- helps prevent sunburn

- higher SPF gives more sunburn protection

- helps provide protection from UVA rays (short and long wavelengths)

Warnings

For external use only

Do not use on

- broken skin

- serious burns

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.

Directions

- apply evenly before sun exposure

- reapply as needed or after towel drying, swimming, or perspiring

- children under 6 months of age: ask a doctor

Inactive ingredients

carbomer homopolymer Type C, carbomer copolymer Type B, cyclomethicone, dimethicone, edetate disodium, glycerin, hydroxypropyl methylcellulose, isopropyl palmitate, methylparaben, phenoxyethanol, propylene glycol, propylparaben, purified water, stearic acid, stearoyl macrogolglycerides, stearyl alcohol, trolamine

Questions?

1-800-308-4516

Monday - Friday (9 a.m. to 5 p.m. EST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS SX DAILY MOISTURIZING SUNSCREEN BROAD SPECTRUM SPF 15 
avobenzone, ecamsule and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 g
ECAMSULE (UNII: M94R1PM439) (ECAMSULE - UNII:M94R1PM439)	ECAMSULE	20 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)
CYCLOMETHICONE (UNII: NMQ347994Z)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
PEG-32 HYDROGENATED PALM GLYCERIDES (UNII: G6EP177239)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-017-01	1 in 1 CARTON	07/29/2014
1		100 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021502	07/29/2014

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
DPT Laboratories, Ltd.		832224526	manufacture(49967-017)

Establishment
Name	Address	ID/FEI	Business Operations
DPT Laboratories, Ltd.		832224690	analysis(49967-017)