| NDC | 49967-921-01, 49967-921-02, 49967-921-03 |
| Set ID | 37570b6c-98f4-482b-af74-4708b987daed |
| Category | HUMAN OTC DRUG LABEL |
| Packager | L'Oreal USA Products Inc |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- Active ingredient
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
-
Directions
For sunscreen use:
- shake well before use
- apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
● limit time in the sun, especially from 10 a.m. – 2 p.m.
● wear long-sleeved shirts, pants, hats, and sunglasses
- children under 6 months of age: Ask a doctor
- Other information
-
Inactive ingredients
water, cyclopentasiloxane, alcohol denat., silica, dicaprylyl ether, styrene/acrylates copolymer, PEG-30 dipolyhydroxystearate, dimethicone, cyclohexasiloxane, polymethylsilsesquioxane, nylon-12, dicaprylyl carbonate, phenoxyethanol, lauryl PEG/PPG-18/18 methicone, sodium chloride, caprylyl glycol, PEG-8 laurate, poly C10-30 alkyl acrylate, disteardimonium hectorite, tocopherol, isostearyl alcohol, p-anisic acid, disodium EDTA, dodecene, poloxamer 407
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS SUPERFLUID UV DEFENSE BROAD SPECTRUM SPF 50 PLUS SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-921 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 107.2 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 32.1 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 60 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 38.6 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ALCOHOL (UNII: 3K9958V90M) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DICAPRYLYL ETHER (UNII: 77JZM5516Z) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE 6 (UNII: XHK3U310BA) NYLON-12 (UNII: 446U8J075B) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) PHENOXYETHANOL (UNII: HIE492ZZ3T) LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX) SODIUM CHLORIDE (UNII: 451W47IQ8X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PEG-8 LAURATE (UNII: 762O8IWA10) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) TOCOPHEROL (UNII: R0ZB2556P8) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) P-ANISIC ACID (UNII: 4SB6Y7DMM3) EDETATE DISODIUM (UNII: 7FLD91C86K) DODECENE (UNII: WYE669F3GR) POLOXAMER 407 (UNII: TUF2IVW3M2) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-921-01 1 in 1 CARTON 12/15/2014 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:49967-921-02 1 in 1 CARTON 12/15/2014 2 125 mL in 1 TUBE; Type 0: Not a Combination Product 3 NDC:49967-921-03 1 in 1 CARTON 12/15/2014 3 5 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/15/2014 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations L'Oreal USA, Inc. 185931458 manufacture(49967-921)
