Indications and uses
helps prevent sunburn higher SPF gives more sunburn protection
helps prevent sunburn higher SPF gives more sunburn protection
apply generously before sun exposure and as needed. apply and reapply as directed to avoid lowering protection. apply to all skin exposed to the sun. children under 6 months of age: ask a doctor
Drug Facts
| Active ingredients | Purpose |
|---|---|
| ENSULIZOLE 2.0% | Sunscreen |
| OCTINOXATE 4.9% | Sunscreen |
For external use only
When using this product
Stop use and ask a doctor if
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
WATER, GLYCERIN, BUTYLENE GLYCOL, CYCLOMETHICONE, DIPROPYLENE GLYCOL, SILICA, DIMETHICONE, TRIETHYLHEXANOIN, DIPHENYLSILOXY PHENYL TRIMETHICONE, BEHENYL ALCOHOL, BEHENETH-20, TRIETHANOLAMINE, METHYL AMINOMETHYLCYCLOHEXANE CARBOXAMIDE HCl, XANTHAN GUM, TOCOPHERYL ACETATE, SODIUM HYALURONATE, SODIUM ACETYLATED HYALURONATE, LAURYL BETAINE, BUPLEURUM FALCATUM ROOT EXTRACT, UNCARIA GAMBIR EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, STEARYL ALCOHOL, SODIUM METAPHOSPHATE, CELLULOSE GUM, TRISODIUM EDTA, ALUMINUM HYDROXIDE, ISOSTEARIC ACID, BHT, ALCOHOL, TOCOPHEROL, PHENOXYETHANOL, SODIUM BENZOATE, FRAGRANCE, TITANIUM DIOXIDE, IRON OXIDES
1-800-906-7503
Distributed by
SHISEIDO COSMETICS (AMERICA) LTD.
NEW YORK, NY 10022
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 52685-380-10 | 2023-09-21 | C162847 | 48780-1 | 97449f38-c095-f6ea-e053-dbdaa90aa703 | cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER |
| 52685-380-10 | 2019-11-13 | C162847 | 48780-1 | 97449f38-c095-f6ea-e053-dbdaa90aa703 | cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Ensulizole | ACTIVE INGREDIENT | 9YQ9DI1W42 | 1 | |
| Octinoxate | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| Ensulizole | ACTIVE MOIETY | 9YQ9DI1W42 | 1 | |
| Octinoxate | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| .ALPHA.-TOCOPHEROL | INACTIVE INGREDIENT | H4N855PNZ1 | 1 | |
| .ALPHA.-TOCOPHEROL ACETATE, DL- | INACTIVE INGREDIENT | WR1WPI7EW8 | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| ALUMINUM HYDROXIDE | INACTIVE INGREDIENT | 5QB0T2IUN0 | 1 | |
| BUPLEURUM FALCATUM ROOT | INACTIVE INGREDIENT | X04E310LUY | 1 | |
| BUTYLATED HYDROXYTOLUENE | INACTIVE INGREDIENT | 1P9D0Z171K | 1 | |
| BUTYLENE GLYCOL | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| CARBOXYMETHYLCELLULOSE SODIUM | INACTIVE INGREDIENT | K679OBS311 | 1 | |
| CYCLOMETHICONE | INACTIVE INGREDIENT | NMQ347994Z | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| DIPROPYLENE GLYCOL | INACTIVE INGREDIENT | E107L85C40 | 1 | |
| DOCOSANOL | INACTIVE INGREDIENT | 9G1OE216XY | 1 | |
| EDETATE TRISODIUM | INACTIVE INGREDIENT | 420IP921MB | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| GREEN TEA LEAF | INACTIVE INGREDIENT | W2ZU1RY8B0 | 1 | |
| HYALURONATE SODIUM | INACTIVE INGREDIENT | YSE9PPT4TH | 1 | |
| ISOSTEARIC ACID | INACTIVE INGREDIENT | X33R8U0062 | 1 | |
| LAURYL BETAINE | INACTIVE INGREDIENT | Y4P927Q133 | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| SODIUM POLYMETAPHOSPHATE | INACTIVE INGREDIENT | P1BM4ZH95L | 1 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| TRIETHYLHEXANOIN | INACTIVE INGREDIENT | 7K3W1BIU6K | 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 |
|---|---|
| 52685-380 | 52685-380-10 |
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 |
|---|---|---|---|---|---|---|
| ALCOHOL | ALCOHOL | 3K9958V90M | LOTION / TOPICAL | 305 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET, FILM COATED / ORAL | 50 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY, METERED / SUBLINGUAL | 29 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE / DENTAL | 0.5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | ENEMA / RECTAL | 150 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET, DELAYED RELEASE / ORAL | 280 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / TOPICAL | 9971 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | GEL, METERED / TOPICAL | 20 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | TABLET, FOR SUSPENSION / ORAL | 0.1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SHAMPOO / TOPICAL | 5 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | GEL / DENTAL | 1.8 %w/w | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 336 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | SUPPOSITORY / VAGINAL | 8.5 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / ORAL | 150.68 mg/1ml | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | INJECTION / INTRA-ARTICULAR | 25 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | LOZENGE / ORAL | 1264 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM, AUGMENTED / TOPICAL | 10 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / AURICULAR (OTIC) | 63.64 %w/v | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET / ORAL | 280 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, EMULSION / INTRAVENOUS | 520 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 2 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | NA | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SYRUP / ORAL | 80 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | SUSPENSION, EXTENDED RELEASE / ORAL | 2.7 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / TOPICAL | 561 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | CREAM / VAGINAL | 56 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVENOUS | 99 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, EXTENDED RELEASE / ORAL | 5 mg | ||
| TROLAMINE | TROLAMINE | 9O3K93S3TK | AEROSOL, FOAM / VAGINAL | 2 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| ISOSTEARIC ACID | ISOSTEARIC ACID | X33R8U0062 | GEL / TOPICAL | 20 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL, FOAM / TOPICAL | 75 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | ENEMA / RECTAL | 60 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, FILM COATED / ORAL | 0.08 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | CAPSULE, EXTENDED RELEASE / ORAL | 4 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | LOTION / TOPICAL | 1 %w/w | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | OINTMENT / TOPICAL | 569 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION, EXTENDED RELEASE / ORAL | 186.8 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SYSTEM / TRANSDERMAL | 35 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | SPRAY / TOPICAL | 3 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 11 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | TABLET, CHEWABLE / ORAL | 24.75 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | CAPSULE, LIQUID FILLED / ORAL | 0.1 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | GUM, CHEWING / BUCCAL | 5 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / ORAL | 602 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | TABLET, DELAYED RELEASE / ORAL | 0.34 mg | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE / ORAL | 14 mg | ||
| DIPROPYLENE GLYCOL | DIPROPYLENE GLYCOL | E107L85C40 | SYSTEM / TRANSDERMAL | 6 mg | ||
| BUTYLATED HYDROXYTOLUENE | BUTYLATED HYDROXYTOLUENE | 1P9D0Z171K | INJECTION / INTRAVENOUS | NA | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | SUSPENSION / OPHTHALMIC | 2 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | DROPS / ORAL | NA |
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 |
|---|---|---|---|---|---|---|
| bef7d41d-70c3-4cb3-a3fa-bbbab6a01868 | 229d2bd6-5c2e-4c01-a6a9-4e5858bb2414 | 2023-09-22 | Warnings | 229d2bd6-5c2e-4c01-a6a9-4e5858bb2414 |
Adverse event summaries are temporarily unavailable. Other product information remains available.