NDC | 49967-125-01 |
Set ID | 1516e35d-ca17-4b66-804c-bf8c32be4934 |
Category | HUMAN OTC DRUG LABEL |
Packager | L'Oreal USA Products Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active ingredients
- Purpose
- Uses
- Warnings
- Contents under pressure.
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
-
Directions
For sunscreen use:
● spray liberally and spread evenly by hand 15 minutes before sun exposure
● hold container 4 to 6 inches from the skin to apply
● do not spray directly into face. Spray on hands then apply to face.
● do not apply in windy conditions
● use in a well-ventilated area
● reapply:
● after 80 minutes of swimming or sweating
● immediately after towel drying
● at least every 2 hours
● 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
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Inactive ingredients
dimethicone, water, isododecane, isononyl isononanoate, PEG-10 dimethicone, styrene/acrylates copolymer, PEG-30 dipolyhydroxystearate, dicaprylyl carbonate, trisiloxane, dimethicone/PEG-10/15 crosspolymer, sodium chloride, phenoxyethanol, PEG-8 laurate, disteardimonium hectorite, p-anisic acid, disodium EDTA, tocopherol, propylene carbonate
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
KIEHLS SINCE 1851 ACTIVATED SUN PROTECTOR BROAD SPECTRUM SPF 50 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene and oxybenzone aerosol, sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-125 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 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 150 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 70 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 60 mg in 1 g Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) ISODODECANE (UNII: A8289P68Y2) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) TRISILOXANE (UNII: 9G1ZW13R0G) SODIUM CHLORIDE (UNII: 451W47IQ8X) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-8 LAURATE (UNII: 762O8IWA10) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) P-ANISIC ACID (UNII: 4SB6Y7DMM3) EDETATE DISODIUM (UNII: 7FLD91C86K) TOCOPHEROL (UNII: R0ZB2556P8) PROPYLENE CARBONATE (UNII: 8D08K3S51E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-125-01 143 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 04/01/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/01/2013 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations Accra Pac, Inc. 024213616 manufacture(49967-125)