INDICATIONS & USAGE SECTION
Repairs wrinkles and limits their formation.
Repairs wrinkles and limits their formation.
Apply in the morning, avoiding the eye contour.
Contains oxybenzone.
Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 10%, Oxybenzone 5%.
Distr. ORLANE Sayreville, N.J. 08872.
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 65371-030-01 | 2020-07-23 | C162847 | 48780-1 | 97449f38-c6ad-f6ea-e053-dbdaa90aa703 | Extreme Anti-Wrinkle Care SPF 30 |
| 65371-030-01 | 2019-11-13 | C162847 | 48780-1 | 97449f38-c6ad-f6ea-e053-dbdaa90aa703 | Extreme Anti-Wrinkle Care SPF 30 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Avobenzone | ACTIVE INGREDIENT | G63QQF2NOX | 1 | |
| Homosalate | ACTIVE INGREDIENT | V06SV4M95S | 1 | |
| Octisalate | ACTIVE INGREDIENT | 4X49Y0596W | 1 | |
| Octocrylene | ACTIVE INGREDIENT | 5A68WGF6WM | 1 | |
| Oxybenzone | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| Avobenzone | ACTIVE MOIETY | G63QQF2NOX | 1 | |
| Homosalate | ACTIVE MOIETY | V06SV4M95S | 1 | |
| Octisalate | ACTIVE MOIETY | 4X49Y0596W | 1 | |
| Octocrylene | ACTIVE MOIETY | 5A68WGF6WM | 1 | |
| Oxybenzone | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| .Alpha.-Tocopherol Acetate | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| Alkyl (C12-15) Benzoate | INACTIVE INGREDIENT | A9EJ3J61HQ | 1 | |
| Aluminum Starch Octenylsuccinate | INACTIVE INGREDIENT | I9PJ0O6294 | 1 | |
| Carbomer 934 | INACTIVE INGREDIENT | Z135WT9208 | 1 | |
| Ceteth-20 | INACTIVE INGREDIENT | I835H2IHHX | 1 | |
| Cetyl Alcohol | INACTIVE INGREDIENT | 936JST6JCN | 1 | |
| Chlorhexidine Gluconate | INACTIVE INGREDIENT | MOR84MUD8E | 1 | |
| Chlorphenesin | INACTIVE INGREDIENT | I670DAL4SZ | 1 | |
| Coriander | INACTIVE INGREDIENT | 1OV56052IK | 1 | |
| Dimethicone | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| Docosanol | INACTIVE INGREDIENT | 9G1OE216XY | 1 | |
| Edetate Sodium | INACTIVE INGREDIENT | MP1J8420LU | 1 | |
| Ethylhexylglycerin | INACTIVE INGREDIENT | 147D247K3P | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| Glyceryl Monostearate | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| Hyaluronate Sodium | INACTIVE INGREDIENT | YSE9PPT4TH | 1 | |
| Jasminum Officinale Flower | INACTIVE INGREDIENT | 0Q8K841432 | 1 | |
| Lactic Acid | INACTIVE INGREDIENT | 33X04XA5AT | 1 | |
| Lysine Hydrochloride | INACTIVE INGREDIENT | JNJ23Q2COM | 1 | |
| O-Cymen-5-Ol | INACTIVE INGREDIENT | H41B6Q1I9L | 1 | |
| PEG-75 Stearate | INACTIVE INGREDIENT | OT38R0N74H | 1 | |
| Pentylene Glycol | INACTIVE INGREDIENT | 50C1307PZG | 1 | |
| Phenoxyethanol | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| Silicon Dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| Sodium Benzoate | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| Sodium Dehydroacetate | INACTIVE INGREDIENT | 8W46YN971G | 1 | |
| Steareth-20 | INACTIVE INGREDIENT | L0Q8IK9E08 | 1 | |
| Tocopherol | INACTIVE INGREDIENT | R0ZB2556P8 | 1 | |
| Trolamine | INACTIVE INGREDIENT | 9O3K93S3TK | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| Xanthan Gum | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 65371-030 | 65371-030-01 |
Every source-derived ingredient row is available through these pages.
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | TABLET, EXTENDED RELEASE / ORAL | 528 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | GEL / TOPICAL | 58 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 mg | ||
| Cetyl Alcohol | CETYL ALCOHOL | 936JST6JCN | OINTMENT / TOPICAL | 7 %w/w | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| Lactic Acid | LACTIC ACID | 33X04XA5AT | SOLUTION / TOPICAL | 7.22 %w/w | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| Glyceryl Monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | AEROSOL, FOAM / TOPICAL | 3.27 %w/w | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL / TOPICAL | 1.05 %w/w | ||
| Glyceryl Monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | LIQUID / TOPICAL | 1 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CREAM / VAGINAL | 60 mg | ||
| Edetate Sodium | EDETATE SODIUM | MP1J8420LU | SOLUTION / OPHTHALMIC | 0.1 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / NASAL | 25 mg/1ml | ||
| Lactic Acid | LACTIC ACID | 33X04XA5AT | GEL / TOPICAL | 30 mg | ||
| Glyceryl Monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | OINTMENT / TOPICAL | 5 %w/w | ||
| Edetate Sodium | EDETATE SODIUM | MP1J8420LU | CAPSULE / ORAL | 1 mg | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | CREAM / TOPICAL | 57 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | TROCHE / ORAL | 948 mg | ||
| Lactic Acid | LACTIC ACID | 33X04XA5AT | CONCENTRATE / ORAL | 50 mg/5ml | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| Hyaluronate Sodium | HYALURONATE SODIUM | YSE9PPT4TH | LOTION / TOPICAL | 0.01 %w/w | ||
| Glyceryl Monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | LOTION / TOPICAL | 177 mg | ||
| Trolamine | TROLAMINE | 9O3K93S3TK | CREAM, AUGMENTED / TOPICAL | 20 mg | ||
| Edetate Sodium | EDETATE SODIUM | MP1J8420LU | INJECTION, SOLUTION / INTRAVENOUS | 0.04 %w/v | ||
| Carbomer 934 | CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | Z135WT9208 | CREAM / TOPICAL | 600 mg | ||
| Edetate Sodium | EDETATE SODIUM | MP1J8420LU | INJECTION / INTRAMUSCULAR | 0.01 %w/v | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | GEL / TOPICAL | 5 mg | ||
| Cetyl Alcohol | CETYL ALCOHOL | 936JST6JCN | CREAM / TOPICAL | 1280 mg | ||
| Edetate Sodium | EDETATE SODIUM | MP1J8420LU | SPONGE / TOPICAL | 0.14 %w/w | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| Cetyl Alcohol | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / VAGINAL | 0.75 %w/w | ||
| Cetyl Alcohol | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / AURICULAR (OTIC) | 1 %w/v | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SUSPENSION / TOPICAL | 0.11 %w/v | ||
| Glyceryl Monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | AEROSOL, FOAM / VAGINAL | 3 %w/w | ||
| Carbomer 934 | CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | Z135WT9208 | TABLET, ORALLY DISINTEGRATING / ORAL | 1 mg | ||
| Lactic Acid | LACTIC ACID | 33X04XA5AT | SUPPOSITORY / VAGINAL | NA | ||
| Carbomer 934 | CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) | Z135WT9208 | CAPSULE / ORAL | 32 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| Hyaluronate Sodium | HYALURONATE SODIUM | YSE9PPT4TH | INJECTION, SUSPENSION / INTRAVITREAL | 23 mg | ||
| Glyceryl Monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CREAM / VAGINAL | 140 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / NASAL | 20 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | CREAM / TOPICAL | 46 mg | ||
| Trolamine | TROLAMINE | 9O3K93S3TK | CREAM / VAGINAL | 56 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 2 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / TOPICAL | 1971 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | SUSPENSION, EXTENDED RELEASE / ORAL | 186.8 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / ORAL | 300 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / TOPICAL | 2.5 %w/w | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SOLUTION / ORAL | 336 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 36 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | SYSTEM / TRANSDERMAL | 35 mg | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SOLUTION / ORAL | 280 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION/ DROPS / ORAL | 23 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| Silicon Dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| .Alpha.-Tocopherol Acetate | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | TABLET / ORAL | 0.5 mg | ||
| Phenoxyethanol | PHENOXYETHANOL | HIE492ZZ3T | LOTION / TOPICAL | 1 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SUSPENSION / SUBCUTANEOUS | 1.6 %w/v |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 90d487ee-2128-430e-8802-8e3ebfaba668 | 72f70466-e485-4423-9e89-33296e94c516 | 2020-07-20 | Warnings | 72f70466-e485-4423-9e89-33296e94c516 |
Adverse event summaries are temporarily unavailable. Other product information remains available.