OTC - ACTIVE INGREDIENT SECTION
active ingredients: octisalate 5.00% [] homosalate 5.00% [] oxybenzone 4.00% [] avobenzone 3.00% [] octocrylene 2.70%
active ingredients: octisalate 5.00% [] homosalate 5.00% [] oxybenzone 4.00% [] avobenzone 3.00% [] octocrylene 2.70%
inactive ingredients: water [] methyl trimethicone [] butylene glycol [] butyloctyl salicylate [] neopentyl glycol diheptanoate [] butyrospermum parkii (shea butter) [] peg-100 stearate [] silica [] dipentaerythrityl tri-polyhydroxystearate [] lauryl peg-9 polydimethylsiloxyethyl dimethicone [] dimethicone [] glyceryl stearate [] laurdimonium hydroxypropyl hydrolyzed soy protein [] rosmarinus officinalis (rosemary) extract [] perilla ocymoides leaf extract [] caffeine [] potassium cetyl phosphate [] sucrose [] styrene/acrylates copolymer [] c30-38 olefin/isopropyl maleate/ma copolymer [] cetyl alcohol [] vp/eicosene copolymer [] ethylhexylglycerin [] ammonium acryloyldimethyltaurate/vp copolymer [] peg-8 laurate [] sodium rna [] lecithin [] arginine ferulate [] tocopheryl acetate [] caprylyl glycol [] ascorbyl tocopheryl maleate [] propyl gallate [] stearic acid [] xanthan gum [] hexylene glycol [] nordihydroguaiaretic acid [] disodium edta [] phenoxyethanol [] sodium dehydroacetate [] mica
to use: apply liberally before sun exposure as needed. Reapply frequently, and after towel drying, swimming or perspiring
children under 6 months of age: ask a doctor
warning: for external use only. 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 right away.
PRINCIPAL DISPLAY PANEL:
CLINIQUE
spf 30
WITH SOLAR SMART
UVA/UVB
ADVANCED PROTECTION
BODY CREAM
5 FL OZ/150 ML
clinique labs inc.
new york, ny 10022
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49527-736-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-89ad-f424-e053-dadaa90a57ce | 53bf57fd-a46f-4c73-aecc-c7fa4e90676b |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49527-736-01 | CLINIQUESPF 30 ADVANCED PROTECTION BODY CREAM with SOLAR SMART | 1 in 1 CARTON | CREAM | 1 | 2 | |
| 49527-736-02 | CLINIQUESPF 30 ADVANCED PROTECTION BODY CREAM with SOLAR SMART | 150 mL in 1 TUBE | CREAM | 150 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49527-736 | CLINIQUE SPF 30 ADVANCED PROTECTION BODY CREAM WITH SOLAR SMART (OCTISALATE, HOMOSALATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE) CREAM [CLINIQUE LABS INC] | 2 | Legacy NDC, 2 package rows | 20110323_53bf57fd-a46f-4c73-aecc-c7fa4e90676b.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| AVOBENZONE | ACTIVE INGREDIENT | G63QQF2NOX | 2 | |
| HOMOSALATE | ACTIVE INGREDIENT | V06SV4M95S | 2 | |
| OCTISALATE | ACTIVE INGREDIENT | 4X49Y0596W | 2 | |
| OCTOCRYLENE | ACTIVE INGREDIENT | 5A68WGF6WM | 2 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | 2 | |
| AVOBENZONE | ACTIVE MOIETY | G63QQF2NOX | 2 | |
| HOMOSALATE | ACTIVE MOIETY | V06SV4M95S | 2 | |
| OCTISALATE | ACTIVE MOIETY | 4X49Y0596W | 2 | |
| OCTOCRYLENE | ACTIVE MOIETY | 5A68WGF6WM | 2 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | 2 | |
| BUTYLENE GLYCOL | INACTIVE INGREDIENT | 3XUS85K0RA | 2 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 2 | |
| GLYCERYL MONOSTEARATE | INACTIVE INGREDIENT | 230OU9XXE4 | 2 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | 2 | |
| METHYL TRIMETHICONE | INACTIVE INGREDIENT | S73ZQI0GXM | 2 | |
| MICA | INACTIVE INGREDIENT | V8A1AW0880 | 2 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 2 | |
| SHEA BUTTER | INACTIVE INGREDIENT | K49155WL9Y | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 2 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 49527-736 | 49527-736-02, 49527-736-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| OCTISALATE | 4X49Y0596W | ACTIB |
| HOMOSALATE | V06SV4M95S | ACTIB |
| OXYBENZONE | 95OOS7VE0Y | ACTIB |
| AVOBENZONE | G63QQF2NOX | ACTIB |
| OCTOCRYLENE | 5A68WGF6WM | ACTIB |
| WATER | 059QF0KO0R | IACT |
| METHYL TRIMETHICONE | S73ZQI0GXM | IACT |
| BUTYLENE GLYCOL | 3XUS85K0RA | IACT |
| SHEA BUTTER | K49155WL9Y | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| DIMETHICONE | 92RU3N3Y1O | IACT |
| GLYCERYL MONOSTEARATE | 230OU9XXE4 | IACT |
| SUCROSE | C151H8M554 | IACT |
| LECITHIN, SOYBEAN | 1DI56QDM62 | IACT |
| PHENOXYETHANOL | HIE492ZZ3T | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| MICA | V8A1AW0880 | IACT |
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 |
|---|---|---|---|---|---|---|
| SUCROSE | SUCROSE | C151H8M554 | SUSPENSION, EXTENDED RELEASE / ORAL | 5400 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION / ORAL | 31885 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | POWDER / ORAL | 27768 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, LIQUID FILLED / ORAL | 106 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / SUBLINGUAL | 10 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC | 0.6 %w/w | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET / BUCCAL | 109 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SOLUTION / ORAL | 280 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | LOTION / TOPICAL | 177 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | LIQUID / ORAL | 37500 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL, FOAM / TOPICAL | 72 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | LOTION / TOPICAL | 1 %w/w | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CREAM / TOPICAL | 836 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, EXTENDED RELEASE / ORAL | 450 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 2 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 336 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE / ORAL | 1190 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION / ORAL | 400 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, DELAYED RELEASE / ORAL | 6 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SOLUTION / RECTAL | 35.42 %w/v | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | SUSPENSION / OPHTHALMIC | 0.5 %w/v | ||
| SUCROSE | SUCROSE | C151H8M554 | CAPSULE, DELAYED RELEASE / ORAL | 955 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | AEROSOL, FOAM / VAGINAL | 3 %w/w | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET / ORAL | 8 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, ORALLY DISINTEGRATING / ORAL | 68 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / ORAL | 602 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PASTE / DENTAL | 34 %w/w | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | LOZENGE / ORAL | 1264 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 119.12 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | CAPSULE / ORAL | 13.75 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET / SUBLINGUAL | 1.23 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET, FILM COATED / ORAL | 0.33 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / DENTAL | 19 %w/w | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SOLUTION / ORAL | 10 mg/5ml | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | CAPSULE / ORAL | 20 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | SYRUP / ORAL | 46400 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | WAFER / ORAL | 155.2 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | INJECTABLE, LIPOSOMAL / INTRAVENOUS | 7560 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | AEROSOL, FOAM / TOPICAL | 0.27 %w/w | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.1 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER, FOR SUSPENSION / ORAL | 2553 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SUSPENSION / ORAL | 600 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, COATED / ORAL | 516.42 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / ORAL | 360 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 2350 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, EXTENDED RELEASE / ORAL | 528 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET, EXTENDED RELEASE / ORAL | 20 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | LOZENGE / ORAL | 120 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM / TOPICAL | 57 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, EXTENDED RELEASE / ORAL | 168 mg | ||
| SUCROSE | SUCROSE | C151H8M554 | TABLET, DELAYED RELEASE / ORAL | 295.33 mg | ||
| GLYCERYL MONOSTEARATE | GLYCERYL MONOSTEARATE | 230OU9XXE4 | GRANULE, FOR SUSPENSION / ORAL | 4 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, DELAYED RELEASE / ORAL | 3.2 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | FILM, SOLUBLE / ORAL | 2 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | PASTE / ORAL | 1050 mg |
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 |
|---|---|---|---|---|---|---|
| dfbb4a0f-2878-48b2-b2d6-96c58c877f14 | 53bf57fd-a46f-4c73-aecc-c7fa4e90676b | 2011-02-14 | Warnings | dfbb4a0f-2878-48b2-b2d6-96c58c877f14 53bf57fd-a46f-4c73-aecc-c7fa4e90676b |
Adverse event summaries are temporarily unavailable. Other product information remains available.