NDC | 49967-017-01 |
Set ID | de3fd7fb-4a28-4db8-9a4d-d7fdd2e45daf |
Category | HUMAN OTC DRUG LABEL |
Packager | L'Oreal USA Products Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | NDA021502 |
- Active ingredients
- Purpose
- Uses
- Warnings
- Do not use on
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
- Directions
-
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?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS SX DAILY MOISTURIZING SUNSCREEN BROAD SPECTRUM SPF 15
avobenzone, ecamsule and octocrylene creamProduct 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)